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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

2026-01-30

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 (1)

CHU Poitiers

Poitiers, France