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

Completed

• Conditions: Acute Respiratory Failure With Hypoxia
• Interventions: Device: non invasive ventilation and high flow nasal canulae oxygen therapy

• Registration Number: NCT04664322
• Lead Sponsor: University Hospital, Rouen

Brief 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.

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 Timeline

• Study Start: 2016-02-22
• Primary Completion: 2018-02-13
• Study Completion: 2018-02-19
• Study First Submitted: 2020-11-19
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-10
• Last Update Submitted: 2020-12-10
• Study First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIV/HFNC	non invasive ventilation and high flow nasal canulae oxygen therapy	patients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy
HFNC/NIV	non invasive ventilation and high flow nasal canulae oxygen therapy	patients receiving high flow nasal canulae oxygen therapy than non-invasive ventilation

Primary Outcome Measures

Name	Time	Method
global EELI	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 Outcome Measures

Name	Time	Method
ROI EELI	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	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	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