Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation

Active, not recruiting

• Conditions: Respiratory Failure With Hypoxia; Respiratory Failure, ICU; High-Flow Nasal Oxygen Therapy

• Registration Number: NCT07030413
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Acute respiratory failure is a frequent reason for admission to the intensive care unit (ICU). It is associated with high healthcare consumption and mortality.

High-flow nasal oxygen (HFNO) improves comfort, reduces the risk of intubation and may reduce the risk of mortality in the most severe patients with acute hypoxemic respiratory failure compared with other oxygenation strategies. Therefore, HFNO is recommended as a first-line non-invasive oxygenation strategy in acute hypoxemic respiratory failure.

The timing of weaning patients from HFNO is complex. On the one hand, failure to wean from HFNO is associated with prolonged duration of HFNO and prolonged ICU stay. On the other hand, continued HFNO in patients ready to be weaned may unnecessarily prolong ICU stay and contribute to overwhelming of ICU capacities.

The overarching goal of this study is to identify the characteristics of patients in whom weaning from HFNO is not beneficial.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Study First Posted: 2025-06-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Adult patients (age > 18)
• Admitted to participating ICUs
• Treated with HFNO at the attending physician's discretion for acute respiratory failure (defined as respiratory rate ≥ 25 breaths/min)

Exclusion Criteria

• Prophylactic HFNO to prevent reintubation after extubation
• Noninvasive ventilation before HFNO initiation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital-free days at day 90	90 days	The number of days alive out of hospital between pseudorandomization and D90. For patients who died, the hospital-free days at day 90 will be equal to 0.

Secondary Outcome Measures

Name	Time	Method
Duration of intensive care unit (ICU) stay	90 days	The number of days spent in the ICU
ICU mortality	90 days	The number (and proportion) of patients who died in the ICU
Survival at day 90	90 days	The number (and proportion) of patients alive at day 90 from pseudorandomization

Trial Locations

Locations (3)

University Hospital Bordeaux; 🇫🇷 Bordeaux, France

University Hospital Limoges; 🇫🇷 Limoges, France

University Hospital Poitiers; 🇫🇷 Poitiers, France