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

NCT ID: NCT04664322

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-22

Study Completion Date

2018-02-19

Brief Summary

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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

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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).

Conditions

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Acute Respiratory Failure With Hypoxia

Keywords

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

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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NIV/HFNC

patients receiving non-invasive ventilation than high flow nasal canulae oxygen therapy

non invasive ventilation and high flow nasal canulae oxygen therapy

Intervention Type DEVICE

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

non invasive ventilation and high flow nasal canulae oxygen therapy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe GIRAULT, MD

Role: STUDY_DIRECTOR

Medical Intensive Care Department, Rouen University Hospital, F-76000 Rouen, France

Other Identifiers

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CPP-CS 001/2015

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A00122-47

Identifier Type: -

Identifier Source: org_study_id