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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure With Hypoxia
• Intervention / Treatment: Device: non invasive ventilation and high flow nasal canulae oxygen therapy

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 Type: Observational
• Enrollment (Actual): 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults referred in ICU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
global EELI	measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit	after 5 minutes of stable breathing with the oxygenation technic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	after 5 minutes of stable breathing with the oxygenation technic

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Study Director: Christophe GIRAULT, MD, Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2016
• Primary Completion (ACTUAL): February 13, 2018
• Study Completion (ACTUAL): February 19, 2018

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: non-invasive ventilation; electrical impedance tomography; alveolar recruitment; high-flow nasal cannula oxygen therapy; hypoxemic acute respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia; Respiratory Distress Syndrome
• Other Study ID Numbers: 2015-A00122-47; CPP-CS 001/2015 (OTHER: CPP Nord Ouest 1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: from the first patient enrollment ( 02/22/2016) to publication
• IPD Sharing Access Criteria: Excel database was shared with biostatisticians for statistical analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No