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CompletedNCT04664322IRAvistaUpdated Jun 4, 2026

High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure

An observational study in Acute Respiratory Failure With Hypoxia, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
16
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Acute Respiratory Failure With Hypoxia

Keywords

  • alveolar recruitment
  • electrical impedance tomography
  • non-invasive ventilation
  • high-flow nasal cannula oxygen therapy
  • hypoxemic acute respiratory failure
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 16 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults referred in ICU

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

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
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Devicenon 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

06

What researchers measure

Primary outcomes

  1. global EELI

    measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit

    Time frame: after 5 minutes of stable breathing with the oxygenation technic

Secondary outcomes

  1. 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

    Time frame: after 5 minutes of stable breathing with the oxygenation technic

  2. global TV

    measurement of global tidal variation (TV) with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit

    Time frame: after 5 minutes of stable breathing with the oxygenation technic

  3. ROI TV

    measurement of regional tidal variation with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit

    Time frame: after 5 minutes of stable breathing with the oxygenation technic

07

Study locations

1 site
  • CHU de ROUEN
    Rouen, 76031, France
08

References and documents

Individual participant data

Plan to share: Yes — all collected IPD

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04664322
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Feb 22, 2016
Primary completion
Feb 13, 2018
Completion
Feb 19, 2018
Last update
Jun 4, 2026

Study contacts

Christophe GIRAULT, MD
study director · Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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