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Compares treatment options for Post Extubation Respiratory Failure
Official title Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units
ClinicalTrials.gov ID: NCT05686850
What this study is testing
- What it's testing
- 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%.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Clinical criterion persisting for at least 30 minutes: a respiratory rate exceeding 25 breaths per minute or clinical signs of respiratory distress...
- 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...
- Informed consent from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy to give consent.
You likely can't join if
- 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...
- Altered consciousness (Glasgow coma scale \< 12)
- Unplanned extubation (accidental or self-extubation)
See the full eligibility 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...
- 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...
- Informed consent from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy to give consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Angers, France
- Argenteuil, France
- Aurillac, France
- Avignon, France
- Belfort, France
- Bordeaux, France
- Bourg-en-Bresse, France
- Brest, France
- Clermont-Ferrand, France
- Colombes, France
- Cornebarrieu, France
- Créteil, France
- Dax, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- La Rochelle, France
- Le Chesnay, France
- Le Mans, France
+ 27 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Angers, France; Argenteuil, France; Aurillac, France; Avignon, France; Belfort, France and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.