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Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units
Sponsor: Poitiers University Hospital
Summary
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.
Official title: Non-Invasive Ventilation Versus High-flow Nasal Oxygen for Post-extubation Respiratory Failure in Intensive Care Units: a Multicenter, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
670
Start Date
2023-02-02
Completion Date
2028-08-27
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
High-Flow Oxygen
Humidified and heated oxygen with a gas flow at least 50 L/min through nasal cannula
Non invasive ventilation
NIV will be carried out in pressure-support mode with a minimal pressure-support level of 5 cmH2O targeting a tidal volume around 6 to 8 mL/kg of predicted bodyweight, a positive end-expiratory pressure (PEEP) level at least 8 cm H2O, and FiO2 adjusted to obtain adequate oxygenation
Locations (47)
Erasme Hospital
Brussels, Belgium
Angers University Hospital
Angers, France
Victor Dupouy Hospital
Argenteuil, France
Henri Mondor Hospital
Aurillac, France
Henri Duffaut Hospital
Avignon, France
Nord-Franche-Comté Hospital
Belfort, France
Bordeaux University Hospital
Bordeaux, France
Fleyriat Hospital
Bourg-en-Bresse, France
Brest University Hospital
Brest, France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France
Louis Mourier Hospital
Colombes, France
Cèdres Clinic
Cornebarrieu, France
Henri Mondor Hospital
Créteil, France
Dax Hospital
Dax, France
Francois Mitterrand Hospital
Dijon, France
Grenoble University Hospital
Grenoble, France
Vendée Hospital
La Roche-sur-Yon, France
La Rochelle Hospital
La Rochelle, France
André Mignot Hospital
Le Chesnay, France
Le Mans Hospital
Le Mans, France
Lens Hospital
Lens, France
Lille University Hospital
Lille, France
Limoges University Hospital
Limoges, France
Saint Joseph Saint Luc Hospital
Lyon, France
La Timone Hospital
Marseille, France
Mont de Marsan Hospital
Mont-de-Marsan, France
Moulins-Yzeure Hospital
Moulins, France
Emile Muller Hospital
Mulhouse, France
Nantes University Hospital
Nantes, France
Nice University Hospital
Nice, France
Orléans University Hospital
Orléans, France
La Pitié Salpêtrière Hospital
Paris, France
Pau Hospital
Pau, France
Poitiers University Hospital
Poitiers, France
Rennes University Hospital
Rennes, France
Rouen University Hospital
Rouen, France
Saint Nazaire Hospital
Saint-Nazaire, France
Saintes Hospital
Saintes, France
Foch Hospital
Suresnes, France
Tours University Hospital
Tours, France
Vannes Hospital
Vannes, France
Pierre Zobda Quitman Hospital
Fort-de-France, Martinique
Felix Guyon Hospital
Saint-Denis, Reunion
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Complejo Hospitalario Universitario de Toledo
Toledo, Spain