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Acute Respiratory FailureNCT04619641

Physiological Effects of a New Interface on Lung Ventilation and Gas Distribution

A study testing High Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP) in people with Acute Respiratory Failure, run by University Magna Graecia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hypoxemic Acute Respiratory Failure (hARF) is a common reason of admission to Intensive Care. Different modalities can be used to administer oxygen, which is the first supportive treatment in these patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Failure
What is being tested?
High Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
1 Dec 2020to 31 Dec 2021
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

  • presence of hypoxemic Acute Respiratory Failure
  • absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency

Who cannot join

  • reduced level of consciousness, as indicated by a Glasgow Coma Scale < 12
  • severe respiratory distress (i.e. respiratory rate > 35 breaths/min)
  • hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion)
  • need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min
  • life-threatening arrhythmias or electrocardiographic signs of ischemia
  • acute respiratory failure secondary to neurological disorders, status asthmaticus, chronic obstructive pulmonary disease (COPD), cardiogenic pulmonary oedema
Show all 13Show fewer
  • presence of tracheotomy
  • uncontrolled vomiting
  • more than 2 acute organ failures
  • body mass index >30 kg/m2
  • documented history or suspicion of obstructive sleep apnoea
  • facial anatomy contraindicating helmet or nasal cannula application
  • contraindications to placement of EIT (i.e., pneumothorax, pulmonary emphysema, chest burns or thoracic surgery within 1 week)

Trial locations and contacts

No sites are listed yet.

Federico Longhini, MD contact

00393475395967

longhini.federico@gmail.com

About this study

Official title: Physiological Effects of a New Interface Combining High-flow Nasal Cannula and Cpap on Lung Ventilation and Gas Distribution in Patients With Mild-to-moderate Acute Respiratory Distress Syndrome: a Pilot Study

Hypoxemic Acute Respiratory Failure (hARF) is a common reason of admission to Intensive Care. Different modalities can be used to administer oxygen, which is the first supportive treatment in these patients. Recently a new device combining high flow nasal cannula (HFNC) and continuous positive airway pressure (CPAP) has been developed, but a few is known in these patients.

Investigators have designed this pilot physiologic randomized cross-over study to assess, in patients with hARF, the effects of a new device combining high-flow oxygen through nasal cannula (HFNC) and continuous positive airway pressure (CPAP) on lung aeration and ventilation distribution .

Read the detailed description

Around 30% of patients admitted to the Intensive Care Unit (ICU) are affected by hypoxemic Acute Respiratory Failure (hARF). The primary supportive treatment in hypoxemic patients is oxygen therapy, which is commonly delivered through nasal prongs or masks. New devices, able to deliver high-flow gas through a nasal cannula (HFNC), have been recently made available. HFNC delivers heated and humidified gas up to 60 L/min, with a fraction of inspired oxygen (FiO2) ranging from 0.21 to 1, via a wide bore soft nasal prong. Warming and humidification of the inspired gas prevent the adverse effects of cool dry gases on the airway epithelium and facilitate expectoration. HFNC also washes out exhaled carbon dioxide (CO2) from the pharyngeal dead space. HFNC has been shown an effective means to deliver oxygen therapy in many clinical conditions.

In healthy subject during spontaneous unassisted breathing, end-expiratory pharyngeal pressure is about 0.3 and 0.8 cmH2O, with open and closed mouth, respectively. Compared to unassisted spontaneous breathing, HFNC generates greater pharyngeal pressure during expiration, while in the course of inspiration it drops to zero, which limits the effectiveness of HFNC in patients with lung edema and/or collapse. By recruiting lung atelectatic regions, reducing venous admixture and decreasing the inspiratory effort, continuous positive airway pressure (CPAP) is likely more effective in these instances. Compared to noninvasive ventilation by application of an inspiratory pressure support, CPAP offers several advantages, which include ease of use and lack of patient-ventilator asynchrony.

CPAP may be applied either through mask or helmet. This latter is better tolerated than facial masks and allows more prolonged continuous CPAP application. When applying CPAP by helmet, however, heating and humidification of the inhaled gas is problematic because of condensation of water inside the interface, so called "fog effect". Moreover, in patients receiving CPAP by helmet some re-breathing occurs.

To overcome these limitations and combine the beneficial effects of HFNC and CPAP, investigators designed a new device combining HFNC and helmet CPAP.

Recently, it has been found this combination capable to provide a stable CPAP and effective CO2 washout from the upper airways with negligible CO2 re-breathing. Nonetheless, because of the complex interplay between CPAP and HFNC, the amount of truly applied airway pressure, diaphragm function and temperature inside the helmet might be affected to some extent. In 14 adult healthy volunteers, we found that adding HFNC to CPAP (as referenced to CPAP), 1) did not importantly alter either the pre-set airway pressure during inspiration or temperature inside the helmet; 2) increased expiratory airway pressure proportionally to the flow administered by HFNC, but to a lower extent than HFNC alone (as referenced to spontaneous breathing); 3) determined only slight modifications of the respiratory drive (as assessed through diaphragm ultrasound), compared to CPAP alone, 4) did not cause "fog effect" inside the helmet and 5) did not worsen comfort. We therefore suggested that adding heated humidified air through nasal cannula at a flow of 30 L/min during CPAP would probably be the best setting to be applied in patients with hypoxemic acute respiratory failure.

Electrical Impedance Tomography (EIT) is a non-invasive bedside monitoring device aimed at assessing lung aeration and ventilation. HFNC and CPAP devices was shown to modify lung aeration and ventilation in patients with hARF. However, nothing is known about the effect of the combination of HFNC+CPAP on lung ventilation in patients with hARF. Investigators have therefore designed this pilot physiologic randomized cross-over study to investigate the effects of HFNC+CPAP on lung aeration and ventilation distribution, gas exchange and patient's comfort.

Being tested
High Flow Nasal Cannula (HFNC), Continuous Positive Airway Pressure (CPAP)

What participants receive

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

  • High Flow Nasal Cannula (HFNC)Device

    HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity

  • Continuous Positive Airway Pressure (CPAP)Device

    CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet

Study groups in NCT04619641
Study groupRoleWhat they receive
High flow nasal cannula (HFNC)Active comparatorHFNC will be applied by means of a dedicated device (AIRVO2, Fisher \& Paykel Healthcare, Auckland, New Zealand). Gas flow will be set at 50 L/min, and humidification chamber will be set at 31°C.
Receives: Device: High Flow Nasal Cannula (HFNC)
Continuous Positive Airway Pressure (CPAP)Active comparatorCPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet.
Receives: Device: Continuous Positive Airway Pressure (CPAP)
HFNC+CPAPActive comparatorHFNC+CPAP consists in the contemporaneous application of HFNC and CPAP through helmet. HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity, while CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the "fog effect" in the helmet
Receives: Device: High Flow Nasal Cannula (HFNC); Device: Continuous Positive Airway Pressure (CPAP)

What is being measured

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

  1. Change of end-expiratory lung impedance (dEELI) from HFNC

    change from HFNC, expressed in percentage of the tidal volume, of the end expiratory lung volume as assessed through electrical impedance tomography

    Measured: After 30 minutes of treatment application

Secondary outcomes (6)
  1. Global Inhomogeneity (GI)

    inhomogeneity of air distribution within the lung as assessed through electrical impedance tomography

    Measured: After 30 minutes of treatment application

  2. Change of tidal volume in percentage (dVt%) from HFNC

    change from HFNC, expressed in percentage, of the tidal volume as assessed through electrical impedance tomography

    Measured: After 30 minutes of treatment application

  3. Arterial partial pressure of oxygen (PaO2)

    Analysis of arterial blood gases

    Measured: After 30 minutes of treatment application

  4. Arterial partial pressure of carbon dioxide (PaCO2)

    Analysis of arterial blood gases

    Measured: After 30 minutes of treatment application

  5. Patient's comfort

    It will be measured using an 11-point Numeric Rating Scale. Briefly, after detailed explanation before initiating the protocol, patients will be asked to indicate a number between 0 (worst possible comfort) and 10 (no discomfort) on an adapted printed scale.

    Measured: After 30 minutes of treatment application

  6. Patient's Dyspnea

    It will be measured using an 11-point Numeric Rating Scale. Briefly, after detailed explanation before initiating the protocol, patients will be asked to indicate a number between 0 (no dyspnoea) and 10 (worst possible dyspnoea) on an adapted printed scale.

    Measured: After 30 minutes of treatment application

Timeline

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

  1. First posted6 Nov 2020
  2. Study start1 Dec 2020 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619641
Sponsor's protocol ID
OptiPAP EIT
Status last verified
Nov 2020
First submitted
2 Nov 2020
Last updated
16 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual patient data will be anonymously shared after reasonable request to the Principal Investigator or Corresponding author

Publications

  • Garofalo E, Bruni A, Pelaia C, Cammarota G, Murabito P, Biamonte E, Abdalla K, Longhini F, Navalesi P. Evaluation of a New Interface Combining High-Flow Nasal Cannula and CPAP. Respir Care. 2019 Oct;64(10):1231-1239. doi: 10.4187/respcare.06871. Epub 2019 Jun 4.

    PubMed 31164484
  • Mauri T, Spinelli E, Mariani M, Guzzardella A, Del Prete C, Carlesso E, Tortolani D, Tagliabue P, Pesenti A, Grasselli G. Nasal High Flow Delivered within the Helmet: A New Noninvasive Respiratory Support. Am J Respir Crit Care Med. 2019 Jan 1;199(1):115-117. doi: 10.1164/rccm.201806-1124LE. No abstract available.

    PubMed 30240275
  • Grieco DL, Menga LS, Raggi V, Bongiovanni F, Anzellotti GM, Tanzarella ES, Bocci MG, Mercurio G, Dell'Anna AM, Eleuteri D, Bello G, Maviglia R, Conti G, Maggiore SM, Antonelli M. Physiological Comparison of High-Flow Nasal Cannula and Helmet Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2020 Feb 1;201(3):303-312. doi: 10.1164/rccm.201904-0841OC.

    PubMed 31687831

Questions about this trial

What is this clinical trial studying?

A study testing High Flow Nasal Cannula (HFNC) and Continuous Positive Airway Pressure (CPAP) in people with Acute Respiratory Failure, run by University Magna Graecia.

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 2 inclusion and 13 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Federico Longhini, MD (00393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of end-expiratory lung impedance (dEELI) from HFNC (time frame: After 30 minutes of treatment application). 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 NCT04619641, which also lists 3 linked publications.

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 16 Nov 2020.

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