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RECRUITING
NCT05686850
NA

Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units

Sponsor: Poitiers University Hospital

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

High-Flow Oxygen

Humidified and heated oxygen with a gas flow at least 50 L/min through nasal cannula

PROCEDURE

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