Acute Respiratory Failure With HypoxiaIRAvistaNCT04664322
High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure
An observational study of Acute Respiratory Failure With Hypoxia, run by University Hospital, Rouen at 1 site in France.
Trial summary
This physiological study showed an increase in regional ventilation with NIV but no difference in alveolar recruitment as compared to HFNC in patients with hypoxemic ARF. Although NIV provided better oxygenation than HFNC, the effect on lung volumes could explain the potentially deleterious effect of NIV in hypoxemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure With Hypoxia
- What is being tested?
- non invasive ventilation and high flow nasal canulae oxygen therapy
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2016to 19 Feb 2018
- Phase
- Observational
- 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
Study population: Adults referred in ICU
Who may be able to join
- Adult patients referred in ICU
- with hypoxemic acute respiratory failure due to a community acquired pneumonia confirmed by chest X ray,
- with PaO2 < 60mmHg in ambient air, without hypercapnia (PaCO2 < 45 mmHg),
- requiring more than 6L/min of O2 on admission with high concentration FM, and justifying HFNC or NIV for the attending ICU physician
Who cannot join
- cardiogenic pulmonary oedema,
- moderate to severe underlying respiratory disease including COPD (chronic obstructive pulmonary disease)
- contraindication to or failure of previous NIV or HFNC with the need for immediate invasive ventilation
- pregnant or breast-feeding women
- carrier of an implantable defibrillator or pacemaker
- body mass index (BMI)>50 kg/m2
- with cutaneous lesion next to the positioning zone of the Pulmovista® (Dräger, Lübeck, Germany) belt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure
This physiological study showed an increase in regional ventilation with NIV but no difference in alveolar recruitment as compared to HFNC in patients with hypoxemic ARF. Although NIV provided better oxygenation than HFNC, the effect on lung volumes could explain the potentially deleterious effect of NIV in hypoxemic ARF, reinforcing the recently developed concept of patient self-inflicted lung injury.
Read the detailed description
Background: High-flow nasal cannula (HFNC) oxygen therapy has recently shown clinical benefits in hypoxemic acute respiratory failure (ARF) patients, while the interest of non-invasive ventilation (NIV) remains debated. The primary endpoint was to compare alveolar recruitment using global end-expiratory electrical lung impedance (EELI) between HFNC and NIV. Secondary endpoints compared regional EELI, lung volumes (global and regional tidal volume variation (TV)), respiratory parameters, hemodynamic tolerance, dyspnea and patient comfort between HFNC and NIV, relative to face mask (FM).
- Conditions
- Acute Respiratory Failure With Hypoxia
- Being tested
- non invasive ventilation and high flow nasal canulae oxygen therapy
- Keywords
- alveolar recruitment, electrical impedance tomography, non-invasive ventilation, high-flow nasal cannula oxygen therapy, hypoxemic acute respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive ventilation and high flow nasal canulae oxygen therapyDevice
patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| NIV/HFNC | patients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy Receives: Device: non invasive ventilation and high flow nasal canulae oxygen therapy | |
| HFNC/NIV | patients receiving high flow nasal canulae oxygen therapy than non-invasive ventilation Receives: Device: non invasive ventilation and high flow nasal canulae oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
global EELI
measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
Measured: after 5 minutes of stable breathing with the oxygenation technic
Secondary outcomes (3)
ROI EELI
measurement of regional of interest (ROI) end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
Measured: after 5 minutes of stable breathing with the oxygenation technic
global TV
measurement of global tidal variation (TV) with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
Measured: after 5 minutes of stable breathing with the oxygenation technic
ROI TV
measurement of regional tidal variation with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
Measured: after 5 minutes of stable breathing with the oxygenation technic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start22 Feb 2016
- Primary completion13 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure With HypoxiaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe GIRAULT, MD, Study director, Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664322
- Sponsor's protocol ID
- 2015-A00122-47
- Other IDs
- CPP-CS 001/2015
- Acronym
- IRAvista
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT04664322
- Acronym / sponsor ID
- IRAvista / 2015-A00122-47
- Conditions
- Acute Respiratory Failure With Hypoxia
- Keywords
- alveolar recruitment, electrical impedance tomography, non-invasive ventilation, high-flow nasal cannula oxygen therapy, hypoxemic acute respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 11 Dec 2020 (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.
This physiological study showed an increase in regional ventilation with NIV but no difference in alveolar recruitment as compared to HFNC in patients with hypoxemic ARF. Although NIV provided better oxygenation than HFNC, the effect on lung volumes could explain the potentially deleterious effect of NIV in hypoxemic ARF, reinforcing the recently developed concept of patient self-inflicted lung injury.
Detailed description
Background: High-flow nasal cannula (HFNC) oxygen therapy has recently shown clinical benefits in hypoxemic acute respiratory failure (ARF) patients, while the interest of non-invasive ventilation (NIV) remains debated. The primary endpoint was to compare alveolar recruitment using global end-expiratory electrical lung impedance (EELI) between HFNC and NIV. Secondary endpoints compared regional EELI, lung volumes (global and regional tidal volume variation (TV)), respiratory parameters, hemodynamic tolerance, dyspnea and patient comfort between HFNC and NIV, relative to face mask (FM).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV/HFNC | – | Device: non invasive ventilation and high flow nasal canulae oxygen therapypatients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy |
| HFNC/NIV | – | Device: non invasive ventilation and high flow nasal canulae oxygen therapypatients receiving high flow nasal canulae oxygen therapy than non-invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults referred in ICU
Key inclusion criteria (4 listed)
- Adult patients referred in ICU
- with hypoxemic acute respiratory failure due to a community acquired pneumonia confirmed by chest X ray,
- with PaO2 < 60mmHg in ambient air, without hypercapnia (PaCO2 < 45 mmHg),
- requiring more than 6L/min of O2 on admission with high concentration FM, and justifying HFNC or NIV for the attending ICU physician
Key exclusion criteria (7 listed)
- cardiogenic pulmonary oedema,
- moderate to severe underlying respiratory disease including COPD (chronic obstructive pulmonary disease)
- contraindication to or failure of previous NIV or HFNC with the need for immediate invasive ventilation
- pregnant or breast-feeding women
- carrier of an implantable defibrillator or pacemaker
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 |
|---|---|---|
| non invasive ventilation and high flow nasal canulae oxygen therapypatients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy | Device | HFNC/NIV, NIV/HFNC |
Primary outcome
global EELI
Time frame: after 5 minutes of stable breathing with the oxygenation technic
measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
3 secondary outcomes
ROI EELI
Time frame: after 5 minutes of stable breathing with the oxygenation technic
global TV
Time frame: after 5 minutes of stable breathing with the oxygenation technic
ROI TV
Time frame: after 5 minutes of stable breathing with the oxygenation technic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Christophe GIRAULT, MD study director
Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure With Hypoxia, run by University Hospital, Rouen 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global EELI (time frame: after 5 minutes of stable breathing with the oxygenation technic). 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 4 Jun 2026.