Interstitial Lung DiseaseIRAPIDPhysioNCT06182956

NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

A study testing Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy and Continuous positive airway pressure in people with Interstitial Lung Disease and Acute Respiratory Failure, run by ADIR Association at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

The objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Interstitial Lung Disease, Acute Respiratory Failure
What is being tested?: Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy and Continuous positive airway pressure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteFrance
Study dates: 1 Jan 2024to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 18 yrs
Hospitalization in intensive care unit
Acute exacerbation of a previously/presently documented diffuse (fibrotic) interstitial lung disease
Dyspnea majoration since at least 1 month
Alveolar or ground-glass opacities on CT-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload
Hypoxemia requiring oxygen flows > 6 L/min

Who cannot join

Contraindication to noninvasive ventilation or high-flow oxygen therapy
Immediate indication to endotracheal intubation or hemodynamic assistance
Body mass index > 40
Presence of a pacemaker or an implantable defibrillator
Presence of cutaneous lesions where Pulmovista® belt should be placed
Moribund patient

Show all 12Show fewer

Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
Protected adult patient (tutorship or curatorship)
Patient deprived of liberty by court or administrative decision
No possibility to install nasogastric tube
Endotracheal or tracheostomy tube requirement during the study
Hemodynamic assistance requirement during the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elise ARTAUD-MACARI, MD contact

+33232885992

elise.artaud-macari@chu-rouen.fr

Maryline LEFORT contact

+33232885992

mlefort@adir-hautenormandie.com

France1 site

ADIR Association
Rouen, 76000
Elise ARTAUD-MACARI, MD, +33232885992, elise.artaud-macari@chu-rouen.fr
David DEBEAUMONT, MD

Other trials in France

About this study

Official title: Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases

Conditions: Interstitial Lung Disease, Acute Respiratory Failure
Being tested: Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy, Continuous positive airway pressure
Keywords: Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy, Respiratory work, Hemodynamics, Diaphragm
Medical subject headings: Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Noninvasive mechanical ventilationDevice
Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.
Nasal high-flow oxygen therapyDevice
Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.
Continuous positive airway pressureDevice
Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

Study groups in NCT06182956
Study group	Role	What they receive
NIV + CPAP + HFO	Experimental	The patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. Receives: Device: Noninvasive mechanical ventilation; Device: Nasal high-flow oxygen therapy; Device: Continuous positive airway pressure
NIV + HFO + CPAP	Experimental	The patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. Receives: Device: Noninvasive mechanical ventilation; Device: Nasal high-flow oxygen therapy; Device: Continuous positive airway pressure
CPAP + NIV + HFO	Experimental	The patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. Receives: Device: Noninvasive mechanical ventilation; Device: Nasal high-flow oxygen therapy; Device: Continuous positive airway pressure
CPAP + HFO + NIV	Experimental	The patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. Receives: Device: Noninvasive mechanical ventilation; Device: Nasal high-flow oxygen therapy; Device: Continuous positive airway pressure
HFO + CPAP + NIV	Experimental	The patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. Receives: Device: Noninvasive mechanical ventilation; Device: Nasal high-flow oxygen therapy; Device: Continuous positive airway pressure
HFO + NIV + CPAP	Experimental	The patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. Receives: Device: Noninvasive mechanical ventilation; Device: Nasal high-flow oxygen therapy; Device: Continuous positive airway pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under noninvasive ventilation (NIV) and high-flow oxygen therapy (HFO) during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device

Secondary outcomes (181)

Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under NIV and continuous positive airway pressure (CPAP) during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under HFO and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under NIV and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under CPAP and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Comparison of Tidal volume under CPAP and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Comparison of Tidal volume under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Comparison of Tidal volume under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Comparison of Tidal volume under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Comparison of Tidal volume under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Comparison of Tidal volume under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Comparison of end-expiratory lung volume under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Comparison of end-expiratory lung volume under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Comparison of end-expiratory lung volume under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Comparison of end-expiratory lung volume under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Comparison of end-expiratory lung volume under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Comparison of end-expiratory lung volume under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Comparison of transpulmonary pressure under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Comparison of transpulmonary pressure under FM and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Comparison of transpulmonary pressure under FM and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Comparison of transpulmonary pressure under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Comparison of transpulmonary pressure under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Comparison of transpulmonary pressure under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Comparison of driving pressure under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Comparison of driving pressure under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Comparison of driving pressure under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Comparison of driving pressure under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Comparison of driving pressure under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Comparison of driving pressure under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Comparison of Global inhomogeneity index under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Comparison of Global inhomogeneity index under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Comparison of Global inhomogeneity index under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Comparison of Global inhomogeneity index under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Comparison of Global inhomogeneity index under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Comparison of Global inhomogeneity index under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Comparison of respiratory rate under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Comparison of respiratory rate under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Comparison of respiratory rate under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Comparison of respiratory rate under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Comparison of respiratory rate under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Comparison of respiratory rate under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
inspiratory time
Comparison of inspiratory time under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure swings
Comparison of oesophagal pressure variations between inspiration and expiration under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure swings
Comparison of oesophagal pressure variations between inspiration and expiration under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure swings
Comparison of oesophagal pressure variations between inspiration and expiration under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure swings
Comparison of oesophagal pressure variations between inspiration and expiration under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure swings
Comparison of oesophagal pressure variations between inspiration and expiration under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure swings
Comparison of oesophagal pressure variations between inspiration and expiration under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure variations
Comparison of transdiaphragmatic pressure variations between inspiration and expiration under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure variations
Comparison of transdiaphragmatic pressure variations between inspiration and expiration under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure variations
Comparison of transdiaphragmatic pressure variations between inspiration and expiration under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure variations
Comparison of transdiaphragmatic pressure variations between inspiration and expiration under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure variations
Comparison of transdiaphragmatic pressure variations between inspiration and expiration under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure variations
Comparison of transdiaphragmatic pressure variations between inspiration and expiration under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure time products
Comparison of transdiaphragmatic pressure time products under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure time products
Comparison of transdiaphragmatic pressure time products under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure time products
Comparison of transdiaphragmatic pressure time products under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure time products
Comparison of transdiaphragmatic pressure time products under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure time products
Comparison of transdiaphragmatic pressure time products under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transdiaphragmatic pressure time products
Comparison of transdiaphragmatic pressure time products under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure time products
Comparison of oesophagal pressure time products under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure time products
Comparison of oesophagal pressure time products under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure time products
Comparison of oesophagal pressure time products under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure time products
Comparison of oesophagal pressure time products under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure time products
Comparison of oesophagal pressure time products under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
oesophagal pressure time products
Comparison of oesophagal pressure time products under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
ultrasound diaphragmatic strain.
Comparison of ultrasound diaphragmatic strain under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
diaphragmatic thickening fraction
Comparison of diaphragmatic thickening fraction under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
diaphragmatic thickening fraction
Comparison of diaphragmatic thickening fraction under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
diaphragmatic thickening fraction
Comparison of diaphragmatic thickening fraction under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
diaphragmatic thickening fraction
Comparison of diaphragmatic thickening fraction under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
diaphragmatic thickening fraction
Comparison of diaphragmatic thickening fraction under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
diaphragmatic thickening fraction
Comparison of diaphragmatic thickening fraction under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak inspiratory flow
Comparison of peak inspiratory flow under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak inspiratory flow
Comparison of peak inspiratory flow under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak inspiratory flow
Comparison of peak inspiratory flow under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak inspiratory flow
Comparison of peak inspiratory flow under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak inspiratory flow
Comparison of peak inspiratory flow under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak inspiratory flow
Comparison of peak inspiratory flow under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak expiratory flow
Comparison of peak expiratory flow under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak expiratory flow
Comparison of peak expiratory flow under FM and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak expiratory flow
Comparison of peak expiratory flow under FM and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak expiratory flow
Comparison of peak expiratory flow under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak expiratory flow
Comparison of peak expiratory flow under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
peak expiratory flow
Comparison of peak expiratory flow under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Systolic arterial pressures
Comparison of Systolic arterial pressures under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Systolic arterial pressures
Comparison of Systolic arterial pressures under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Systolic arterial pressures
Comparison of Systolic arterial pressures under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Systolic arterial pressures
Comparison of Systolic arterial pressures under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Systolic arterial pressures
Comparison of Systolic arterial pressures under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Systolic arterial pressures
Comparison of Systolic arterial pressures under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Diastolic arterial pressures
Comparison of Diastolic arterial pressures under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Diastolic arterial pressures
Comparison of Diastolic arterial pressures under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Diastolic arterial pressures
Comparison of Diastolic arterial pressures under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Diastolic arterial pressures
Comparison of Diastolic arterial pressures under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Diastolic arterial pressures
Comparison of Diastolic arterial pressures under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Diastolic arterial pressures
Comparison of Diastolic arterial pressures under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Mean arterial pressure
Comparison of Mean arterial pressures under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Mean arterial pressure
Comparison of Mean arterial pressures under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Mean arterial pressure
Comparison of Mean arterial pressures under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Mean arterial pressure
Comparison of Mean arterial pressures under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Mean arterial pressure
Comparison of Mean arterial pressures under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Mean arterial pressure
Comparison of Mean arterial pressures under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
systolic pulmonary arterial pressure
Comparison of systolic pulmonary arterial pressure under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
systolic pulmonary arterial pressure
Comparison of systolic pulmonary arterial pressure under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
systolic pulmonary arterial pressure
Comparison of systolic pulmonary arterial pressure under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
systolic pulmonary arterial pressure
Comparison of systolic pulmonary arterial pressure under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
systolic pulmonary arterial pressure
Comparison of systolic pulmonary arterial pressure under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
systolic pulmonary arterial pressure
Comparison of systolic pulmonary arterial pressure under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
tricuspid annular plane systolic excursion
Comparison of tricuspid annular plane systolic excursion under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
tricuspid annular plane systolic excursion
Comparison of tricuspid annular plane systolic excursion under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
tricuspid annular plane systolic excursion
Comparison of tricuspid annular plane systolic excursion under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
tricuspid annular plane systolic excursion
Comparison of tricuspid annular plane systolic excursion under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
tricuspid annular plane systolic excursion
Comparison of tricuspid annular plane systolic excursion under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
tricuspid annular plane systolic excursion
Comparison of tricuspid annular plane systolic excursion under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right ventricular strain
Comparison of right ventricular strain under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right ventricular strain
Comparison of right ventricular strain under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right ventricular strain
Comparison of right ventricular strain under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right ventricular strain
Comparison of right ventricular strain under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right ventricular strain
Comparison of right ventricular strain under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right ventricular strain
Comparison of right ventricular strain under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
left ventricular ejection fraction
Comparison of left ventricular ejection fraction under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
left ventricular ejection fraction
Comparison of left ventricular ejection fraction under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
left ventricular ejection fraction
Comparison of left ventricular ejection fraction under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
left ventricular ejection fraction
Comparison of left ventricular ejection fraction under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
left ventricular ejection fraction
Comparison of left ventricular ejection fraction under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
left ventricular ejection fraction
Comparison of left ventricular ejection fraction under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
E/E' ratio
Comparison of E/E' ratio under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
E/E' ratio
Comparison of E/E' ratio under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
E/E' ratio
Comparison of E/E' ratio under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
E/E' ratio
Comparison of E/E' ratio under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
E/E' ratio
Comparison of E/E' ratio under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
E/E' ratio
Comparison of E/E' ratio under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right auricular pressure
Comparison of right auricular pressure under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right auricular pressure
Comparison of right auricular pressure under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right auricular pressure
Comparison of right auricular pressure under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right auricular pressure
Comparison of right auricular pressure under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right auricular pressure
Comparison of right auricular pressure under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
right auricular pressure
Comparison of right auricular pressure under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
cardiac output
Comparison of cardiac output under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
cardiac output
Comparison of cardiac output under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
cardiac output
Comparison of cardiac output under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
cardiac output
Comparison of cardiac output under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
cardiac output
Comparison of cardiac output under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
cardiac output
Comparison of cardiac output under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
heart rate
Comparison of heart rate under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
heart rate
Comparison of heart rate under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
heart rate
Comparison of heart rate under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
heart rate
Comparison of heart rate under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
heart rate
Comparison of heart rate under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
heart rate
Comparison of heart rate under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulsed oxymetry
Comparison of pulsed oxymetry under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulsed oxymetry
Comparison of pulsed oxymetry under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulsed oxymetry
Comparison of pulsed oxymetry under NIV and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulsed oxymetry
Comparison of pulsed oxymetry under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulsed oxymetry
Comparison of pulsed oxymetry under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulsed oxymetry
Comparison of pulsed oxymetry under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transcutaneous carbon dioxide pressure
Comparison of transcutaneous carbon dioxide pressure under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transcutaneous carbon dioxide pressure
Comparison of transcutaneous carbon dioxide pressure under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transcutaneous carbon dioxide pressure
Comparison of transcutaneous carbon dioxide pressure under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transcutaneous carbon dioxide pressure
Comparison of transcutaneous carbon dioxide pressure under FM and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transcutaneous carbon dioxide pressure
Comparison of transcutaneous carbon dioxide pressure under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transcutaneous carbon dioxide pressure
Comparison of transcutaneous carbon dioxide pressure under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Dyspnea
Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Dyspnea
Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Dyspnea
Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Dyspnea
Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Dyspnea
Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Dyspnea
Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under FM and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of Comfort
Visual comfort scale (from 0 to 10, 10 is maximal confort) under FM and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of Comfort
Visual comfort scale (from 0 to 10, 10 is maximal confort) under FM and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of Comfort
Visual comfort scale (from 0 to 10, 10 is maximal confort) under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of Comfort
Visual comfort scale (from 0 to 10, 10 is maximal confort) under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of Comfort
Visual comfort scale (from 0 to 10, 10 is maximal confort) under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of Comfort
Visual comfort scale (from 0 to 10, 10 is maximal confort) under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Measured: During the intervention, after an exposure of 30 minutes to the oxygen therapy device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Dec 2026

First posted27 Dec 2023
Study start1 Jan 2024 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06182956
Sponsor's protocol ID: IRAPIDPhysio
Acronym: IRAPIDPhysio
Status last verified: Dec 2023
First submitted: 22 Aug 2023
Last updated: 27 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Elise ARTAUD-MACARI, MD

+33232885992

elise.artaud-macari@chu-rouen.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
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RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
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RecruitingPhase 2
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All Interstitial Lung Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases
ClinicalTrials.gov ID: NCT06182956
Acronym / sponsor ID: IRAPIDPhysio / IRAPIDPhysio
Conditions: Interstitial Lung Disease, Acute Respiratory Failure
Keywords: Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy, Respiratory work, Hemodynamics, Diaphragm
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 18 participants (estimated)
Lead sponsor: ADIR AssociationUniversity, hospital or other
Study start: 1 Jan 2024 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 27 Dec 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
NIV + CPAP + HFO	Experimental	Device: Noninvasive mechanical ventilation, Device: Nasal high-flow oxygen therapy, Device: Continuous positive airway pressureThe patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.
NIV + HFO + CPAP	Experimental	Device: Noninvasive mechanical ventilation, Device: Nasal high-flow oxygen therapy, Device: Continuous positive airway pressureThe patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.
CPAP + NIV + HFO	Experimental	Device: Noninvasive mechanical ventilation, Device: Nasal high-flow oxygen therapy, Device: Continuous positive airway pressureThe patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.
CPAP + HFO + NIV	Experimental	Device: Noninvasive mechanical ventilation, Device: Nasal high-flow oxygen therapy, Device: Continuous positive airway pressureThe patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.
HFO + CPAP + NIV	Experimental	Device: Noninvasive mechanical ventilation, Device: Nasal high-flow oxygen therapy, Device: Continuous positive airway pressureThe patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.
HFO + NIV + CPAP	Experimental	Device: Noninvasive mechanical ventilation, Device: Nasal high-flow oxygen therapy, Device: Continuous positive airway pressureThe patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age > 18 yrs
Hospitalization in intensive care unit
Acute exacerbation of a previously/presently documented diffuse (fibrotic) interstitial lung disease
Dyspnea majoration since at least 1 month
Alveolar or ground-glass opacities on CT-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload

Key exclusion criteria (12 listed)

Contraindication to noninvasive ventilation or high-flow oxygen therapy
Immediate indication to endotracheal intubation or hemodynamic assistance
Body mass index > 40
Presence of a pacemaker or an implantable defibrillator
Presence of cutaneous lesions where Pulmovista® belt should be placed

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Noninvasive mechanical ventilationNoninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.	Device	CPAP + HFO + NIV, CPAP + NIV + HFO, HFO + CPAP + NIV, HFO + NIV + CPAP, NIV + CPAP + HFO, NIV + HFO + CPAP
Nasal high-flow oxygen therapyNasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.	Device	CPAP + HFO + NIV, CPAP + NIV + HFO, HFO + CPAP + NIV, HFO + NIV + CPAP, NIV + CPAP + HFO, NIV + HFO + CPAP
Continuous positive airway pressureContinuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.	Device	CPAP + HFO + NIV, CPAP + NIV + HFO, HFO + CPAP + NIV, HFO + NIV + CPAP, NIV + CPAP + HFO, NIV + HFO + CPAP

Primary outcome

Pulmonary compliance
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of global pulmonary compliance (Cglob) under noninvasive ventilation (NIV) and high-flow oxygen therapy (HFO) during acute respiratory failure in diffuse interstitial pneumonia.

181 secondary outcomes

Pulmonary compliance
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Pulmonary compliance
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Tidal volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
end-expiratory lung volume
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
transpulmonary pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
driving pressure
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Global inhomogeneity index
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
respiratory rate
Time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.

Related trials for Interstitial Lung Disease

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Elise ARTAUD-MACARI, MD contact

+33232885992

elise.artaud-macari@chu-rouen.fr

Maryline LEFORT contact

+33232885992

mlefort@adir-hautenormandie.com

Elise ARTAUD-MACARI, MD principal investigator

University Hospital, Rouen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elise ARTAUD-MACARI, MD (+33232885992, elise.artaud-macari@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary compliance (time frame: During the intervention, after an exposure of 30 minutes to the oxygen therapy device). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06182956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.