Comparing Non-Invasive Ventilation and High-Flow Nasal Oxygen for Respiratory Failure
Non-Invasive Ventilation Versus High-flow Nasal Oxygen for Post-extubation Respiratory Failure in Intensive Care Units: a Multicenter, Randomized, Controlled Trial
This study is testing whether using non-invasive ventilation or high-flow nasal oxygen can help ICU patients who have trouble breathing after being taken off a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 670 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT05686850 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone more than 24 hours of invasive mechanical ventilation and develop respiratory failure within seven days after extubation.
Not a fit: Patients who do not experience respiratory failure after extubation or those who have not been on invasive mechanical ventilation for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective non-invasive treatment option for patients experiencing respiratory failure after extubation.
How similar studies have performed: While previous studies have indicated risks associated with NIV, this approach of comparing NIV with high-flow nasal oxygen specifically for post-extubation respiratory failure has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Poitiers
- CHU Poitiers — Poitiers, France (Recruiting)
Study contacts
- Principal investigator: Arnaud W. THILLE, PhD — CHU Poitiers
- Study coordinator: Arnaud W. THILLE, PhD
- Email: arnaud.thille@chu-poitiers.fr
- Phone: 0549444007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.