Comparing Non-Invasive Ventilation and High-Flow Nasal Oxygen for Respiratory Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of non-invasive ventilation (NIV) and high-flow nasal oxygen in treating post-extubation respiratory failure in intensive care unit patients. Approximately 20% of patients experience respiratory failure after extubation, with a significant risk of reintubation and high mortality rates. The study will assess whether alternating between NIV and high-flow nasal oxygen can improve outcomes compared to standard oxygen therapy. The trial will include patients who have been on invasive mechanical ventilation for more than 24 hours and develop respiratory failure within seven days post-extubation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 (see criteria below). As in several previous studies, post-extubation respiratory failure will be defined by the presence of the 2 following criteria combining a clinical criterion and a blood gas criterion:

  * Clinical criterion persisting for at least 30 minutes: a respiratory rate exceeding 25 breaths per minute or clinical signs of respiratory distress with increased accessory muscle activity.
  * Blood gas criterion: Hypoxemia defined as PaO2/FiO2 ratio below 150 mm Hg or respiratory acidosis defined as pH below 7.35 units and PaCO2 above 45 mm Hg. For patients under standard oxygen, FiO2 will calculated according to the following formula: FiO2 = 0.21 + 0.03 x (oxygen flow L/min).
* Informed consent from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy to give consent.

Exclusion Criteria:

* NIV at home
* ICU admission for peripheral neuromuscular disease type Guillain-Barré syndrome or myasthenia gravis.
* Upper airway obstruction as main reason for post-extubation respiratory failure
* Urgent need for reintubation (respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, or severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support)
* Altered consciousness (Glasgow coma scale \< 12)
* Unplanned extubation (accidental or self-extubation)
* Do-not-reintubate order at time of respiratory failure
* Patient previously included in the study
* People under protection (minors, persons deprived of liberty by a judicial or administrative decision, adults under law protection)
* Patient not affiliated to health care system.

Where it's running

• Erasme Hospital
  Brussels, Belgium Recruiting
• Angers University Hospital
  Angers, France Recruiting
• Victor Dupouy Hospital
  Argenteuil, France Recruiting
• Henri Mondor Hospital
  Aurillac, France Recruiting
• Henri Duffaut Hospital
  Avignon, France Recruiting
• Nord-Franche-Comté Hospital
  Belfort, France Recruiting

Study contacts

• Principal investigator: Arnaud W. THILLE, PhD — CHU Poitiers
• Study coordinator: Arnaud W. THILLE
• Email: THILLE Arnaud <Arnaud.THILLE@chu-poitiers.fr>
• Phone: 0549444444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.