Interstitial Lung DiseaseHighFlowMuscNCT05372926
Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases
A study testing high flow nasal canulae and Ventury mask in people with Interstitial Lung Disease and Pulmonary Rehabilitation, run by ADIR Association at 1 site in France.
Trial summary
in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (HFNC) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ILD) during an endurance test Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Pulmonary Rehabilitation
- What is being tested?
- high flow nasal canulae and Ventury mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2022to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Cared for as part of a respiratory rehabilitation program (ADIR association)
- Presenting diffuse fibrosing interstitial pneumonitis, documented by CT scan data and whatever its etiology
- Presenting severe hypoxemia in ambient air (SpO2<90%) during an exercise test (6-minute walk test or functional exercise test)
Who cannot join
- Patient with a contraindication to carrying out a respiratory rehabilitation program
- Patient having presented an exacerbation of PID, pneumothorax or pneumomediastinum in the 3 months preceding potential inclusion
- Tracheostomized patient
- Patient with a contraindication to the placement of a nasogastric tube
- Pregnant or breastfeeding women or women of childbearing age without effective means of contraception (a pregnancy test will be carried out)
- Protected adult patient (guardianship or curatorship)
- Patient deprived of liberty by court or administrative decision
- Refusal of patient participation or consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ADIR association
Bois-Guillaume, 76230
Elise ARTAUD-MACARI, MD, +3332 88 59 92, eliseartaudmacari@yahoo.fr
Clémence ROUSSEL
About this study
Official title: Evaluation of the Physiological Effects of High Flow Nasal Canulae Oxygen Therapy During Exercise in Patients With Fibrosing Interstitial Lung Diseases
in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (HFNC) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ILD) during an endurance test
- Being tested
- high flow nasal canulae, Ventury mask
- Keywords
- interstitial lung disease, nasal high flow oxygen therapy, endurance test, pulmonary rehabilitation
- 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.
high flow nasal canulaeDevice
high flow nasal canulae is a oxygen therapy technic which allows the administration of warmed and humidified oxygen with a flow up to 50L/Min and a monitored FiO2. Physiological previous studies reported various effects of this technic especially on work of breathing. In our study the investigators aim to test this physiological property during exercise.
Ventury maskDevice
Ventury mask is a oxygen therapy technic which allows the administration with a mask of oxygen with a flow up to 15L/Min and a monitored FiO2.
| Study group | Role | What they receive |
|---|---|---|
| Venturi mask | Experimental | Patients will be placed under oxygen therapy with Venturi mask at a constant flow of 15L/min and a set FiO2 of 50%. The real FiO2 will be mesured in the mask at rest. Receives: Device: Ventury mask |
| High flow nasal canulae | Experimental | Patients will be placed under high flow nasal canulae oxygen therapy with a constant flow of 50L/min and the real FiO2 provided by Venturi mask. Receives: Device: high flow nasal canulae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ptdi swing
To compare the change in transdiaphragmatic pressure between baseline and peak during inspiration (Ptdi swing) between HFNC and VM in patients with fibrosing Interstitial Lung Disease in stable state, at isotime.
Measured: during the intervention, at isotime
Secondary outcomes (7)
PTPdi
on effort at isotime, comparison between HFNC and VM of diaphragmatic pressure time product during a respiratory cycle (PTPdi)
Measured: during the intervention, at isotime
PTPoeso
on effort at isotime, comparison between HFNC and VM of the respiratory "Pressure Time Product" during a respiratory cycle (PTPoeso)
Measured: during the intervention, at isotime
Poeso swing
on effort at isotime, comparison between HFNC and VM of variation of oesophagal pressure between the base state and the peak (Poeso swing)
Measured: during the intervention, at isotime
DeltaPtdi/DeltaEAdi
on effort at isotime, comparison between HFNC and VM of the electromechanical coupling of the diaphragm (ratio of variation of the transdiaphragmatic pressure by the variation of electrical activity of the diaphragm (EAdi) between the start of inspiration and the end of expiration, (DeltaPtdi/DeltaEAdi)
Measured: during the intervention, at isotime
SmO2
on effort at isotime, comparison between HFNC and VM of the measurement of tissue saturation in oxygen (SmO2) by "Near Infrared Spectrometry" (NIRS)
Measured: during the intervention, at isotime
TcCO2
on effort at isotime, comparison between HFNC and VM of transcutaneous CO2 measurement (TcCO2)
Measured: during the intervention, at isotime
Tlim
Comparison of endurance time (Tlim) between HFNC and VM
Measured: during the intervention, at the end of endurance test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start22 Nov 2022
- Primary completion23 Nov 2024 (estimated)
- Study completion23 Nov 2024 (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
- Model description
- All patients were randomly allocated into two groups using the block randomization technique (blocks of eight patients) in a 1:1 ratio. In group A, a high-intensity constant work-rate endurance test using Venturi mask (VM) was performed on first, and a test using high-flow nasal canulae oxygen therapy (HFNC) was performed next. In group B, a high-intensity CWRET using HFNC was performed first, and a test using VM was performed next.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise ARTAUD-MACARI, MD, Principal investigator, ADIR Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372926
- Sponsor's protocol ID
- HighFlowMusc
- Acronym
- HighFlowMusc
- Status last verified
- Nov 2022
- First submitted
- 6 Apr 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Physiological Effects of High Flow Nasal Canulae Oxygen Therapy During Exercise in Patients With Fibrosing Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT05372926
- Acronym / sponsor ID
- HighFlowMusc / HighFlowMusc
- Keywords
- interstitial lung disease, nasal high flow oxygen therapy, endurance test, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 23 Nov 2024 (estimated)
- Study completion
- 23 Nov 2024 (estimated)
- First posted
- 13 May 2022 (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.
in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (HFNC) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ILD) during an endurance test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients were randomly allocated into two groups using the block randomization technique (blocks of eight patients) in a 1:1 ratio. In group A, a high-intensity constant work-rate endurance test using Venturi mask (VM) was performed on first, and a test using high-flow nasal canulae oxygen therapy (HFNC) was performed next. In group B, a high-intensity CWRET using HFNC was performed first, and a test using VM was performed next.
| Arm | Type | Receives |
|---|---|---|
| Venturi mask | Experimental | Device: Ventury maskPatients will be placed under oxygen therapy with Venturi mask at a constant flow of 15L/min and a set FiO2 of 50%. The real FiO2 will be mesured in the mask at rest. |
| High flow nasal canulae | Experimental | Device: high flow nasal canulaePatients will be placed under high flow nasal canulae oxygen therapy with a constant flow of 50L/min and the real FiO2 provided by Venturi mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cared for as part of a respiratory rehabilitation program (ADIR association)
- Presenting diffuse fibrosing interstitial pneumonitis, documented by CT scan data and whatever its etiology
- Presenting severe hypoxemia in ambient air (SpO2<90%) during an exercise test (6-minute walk test or functional exercise test)
Key exclusion criteria (8 listed)
- Patient with a contraindication to carrying out a respiratory rehabilitation program
- Patient having presented an exacerbation of PID, pneumothorax or pneumomediastinum in the 3 months preceding potential inclusion
- Tracheostomized patient
- Patient with a contraindication to the placement of a nasogastric tube
- Pregnant or breastfeeding women or women of childbearing age without effective means of contraception (a pregnancy test will be carried out)
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 |
|---|---|---|
| high flow nasal canulaehigh flow nasal canulae is a oxygen therapy technic which allows the administration of warmed and humidified oxygen with a flow up to 50L/Min and a monitored FiO2. Physiological previous studies reported various effects of this technic especially on work of breathing. In our study the investigators aim to test this physiological property during exercise. | Device | High flow nasal canulae |
| Ventury maskVentury mask is a oxygen therapy technic which allows the administration with a mask of oxygen with a flow up to 15L/Min and a monitored FiO2. | Device | Venturi mask |
Primary outcome
Ptdi swing
Time frame: during the intervention, at isotime
To compare the change in transdiaphragmatic pressure between baseline and peak during inspiration (Ptdi swing) between HFNC and VM in patients with fibrosing Interstitial Lung Disease in stable state, at isotime.
7 secondary outcomes
PTPdi
Time frame: during the intervention, at isotime
PTPoeso
Time frame: during the intervention, at isotime
Poeso swing
Time frame: during the intervention, at isotime
DeltaPtdi/DeltaEAdi
Time frame: during the intervention, at isotime
SmO2
Time frame: during the intervention, at isotime
TcCO2
Time frame: during the intervention, at isotime
Tlim
Time frame: during the intervention, at the end of endurance test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
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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. This study is not recruiting at the moment.
Elise ARTAUD-MACARI, MD principal investigator
ADIR Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal canulae and Ventury mask in people with Interstitial Lung Disease and Pulmonary Rehabilitation, run by ADIR Association at 1 site in France.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise ARTAUD-MACARI, MD (+3332 88 59 92, eliseartaudmacari@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ptdi swing (time frame: during the intervention, at isotime). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2022.