Actively Recruiting
Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units
Led by Poitiers University Hospital · Updated on 2026-01-30
670
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In intensive care units (ICUs), around 20% of patients experience respiratory failure after planned extubation. Nearly 40-50% of them eventually require reintubation with subsequently high mortality rates reaching 30-40%. NIV used as rescue therapy to treat post-extubation respiratory failure could increase the risk of death. However, NIV may avoid reintubation in a number of cases, and recent large-scale clinical trials on extubation have shown that around 40 to 50% of patients with post-extubation respiratory failure are actually treated with NIV. Whereas high-flow nasal oxygen has never been specifically studied for management of post-extubation respiratory failure, this respiratory support could also in this setting constitute an alternative to standard oxygen or NIV. Given the best noninvasive respiratory support strategy in patients with post-extubation respiratory failure remains unknown, we have decided to assess whether NIV alternating with high-flow nasal oxygen as compared to high-flow nasal oxygen alone may decrease mortality of patients in ICUs with post-extubation respiratory failure.
CONDITIONS
Official Title
Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Duration of invasive mechanical ventilation of more than 24h in the ICU before extubation.
- Post-extubation respiratory failure occurring within the first 7 days after extubation.
- Presence of clinical signs for at least 30 minutes: respiratory rate over 25 breaths per minute or signs of respiratory distress with increased accessory muscle use.
- Blood gas criteria: hypoxemia with PaO2/FiO2 ratio below 150 mm Hg or respiratory acidosis with pH below 7.35 and PaCO2 above 45 mm Hg.
- Informed consent from the patient or relatives, or emergency inclusion if consent cannot be obtained.
You will not qualify if you...
- Use of non-invasive ventilation at home.
- ICU admission for Guillain-Barré syndrome or myasthenia gravis.
- Upper airway obstruction as main cause of post-extubation respiratory failure.
- Urgent need for reintubation due to respiratory or cardiac arrest, respiratory pauses with loss of consciousness, gasping for air, or severe hypoxemia (SpO2 below 90% despite maximal oxygen support).
- Altered consciousness with Glasgow coma scale less than 12.
- Unplanned extubation (accidental or self-extubation).
- Do-not-reintubate order at time of respiratory failure.
- Previous inclusion in this study.
- Persons under legal protection (minors, judicial or administrative detention, or adults under legal protection).
- Not affiliated to the health care system.
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Poitiers
Poitiers, France
Actively Recruiting
Research Team
A
Arnaud W. THILLE, PhD
CONTACT
C
Céline DELETAGE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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