High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure (IRAvista)
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ClinicalTrials.gov Identifier: NCT04664322 |
Recruitment Status :
Completed
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
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Condition or disease | Intervention/treatment |
---|---|
Acute Respiratory Failure With Hypoxia | Device: non invasive ventilation and high flow nasal canulae oxygen therapy |
Study Type : | Observational |
Actual Enrollment : | 16 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Prospective |
Official Title: | High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure |
Actual Study Start Date : | February 22, 2016 |
Actual Primary Completion Date : | February 13, 2018 |
Actual Study Completion Date : | February 19, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
NIV/HFNC
patients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy
|
Device: non invasive ventilation and high flow nasal canulae oxygen therapy
patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy |
HFNC/NIV
patients receiving high flow nasal canulae oxygen therapy than non-invasive ventilation
|
Device: non invasive ventilation and high flow nasal canulae oxygen therapy
patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy |
- 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
- ROI EELI [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]measurement of regional of interest (ROI) end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
- global TV [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]measurement of global tidal variation (TV) with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit
- ROI TV [ Time Frame: after 5 minutes of stable breathing with the oxygenation technic ]measurement of regional tidal variation with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664322
Study Director: | Christophe GIRAULT, MD | Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France |
Responsible Party: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT04664322 |
Other Study ID Numbers: |
2015-A00122-47 CPP-CS 001/2015 ( Other Identifier: CPP Nord Ouest 1 ) |
First Posted: | December 11, 2020 Key Record Dates |
Last Update Posted: | December 11, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | all collected IPD |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | from the first patient enrollment ( 02/22/2016) to publication |
Access Criteria: | Excel database was shared with biostatisticians for statistical analysis |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
alveolar recruitment electrical impedance tomography non-invasive ventilation high-flow nasal cannula oxygen therapy hypoxemic acute respiratory failure |
Respiratory Insufficiency Respiratory Distress Syndrome Hypoxia Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Lung Diseases |