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

NCT05686850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Post Extubation Respiratory Failure

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

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Arnaud W. THILLE, PhD · CHU Poitiers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2028-02-27
Completion
2028-08-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05686850 on ClinicalTrials.gov