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Clinical Trials/NCT04664322
NCT04664322
Completed
N/A

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

University Hospital, Rouen0 sites16 target enrollmentFebruary 22, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Respiratory Failure With Hypoxia
Sponsor
University Hospital, Rouen
Enrollment
16
Primary Endpoint
global EELI
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 22, 2016
End Date
February 19, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • ROI EELI(after 5 minutes of stable breathing with the oxygenation technic)
  • global TV(after 5 minutes of stable breathing with the oxygenation technic)
  • ROI TV(after 5 minutes of stable breathing with the oxygenation technic)

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