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Completed

NCT Number: NCT04664322

High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison 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.

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Key information

Conditions

Acute Respiratory Failure With Hypoxia Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de ROUEN

Rouen, 76031, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non invasive ventilation and high flow nasal canulae oxygen therapy

Device

patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure

Acronym: IRAvista

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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