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

NCT07030413 | Active Not Recruiting

• 1 other identifier: HFNO-Weaning
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

high-flow nasal oxygen therapy; acute hypoxemic respiratory failure; weaning

Outcome Measures

Primary Outcomes (1)

• Hospital-free days at day 90

  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.

  90 days

Secondary Outcomes (3)

• Duration of intensive care unit (ICU) stay

  90 days

• ICU mortality

  90 days

• Survival at day 90

  90 days

Study Arms (2)

HFNO weaning trial group

Patients who underwent at least one weaning trial from HFNO

No HFNO weaning trial group

Patients who did not underwent HFNO weaning trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All ICU patients admitted to the 3 participating centers and treated with HFNO at the attending physician's discretion for acute respiratory failure.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• University Hospital, Bordeaux: collaborator
• University Hospital, Limoges: collaborator

Study Sites (3)

University Hospital Bordeaux

Bordeaux, 33400, France

Location

University Hospital Limoges

Limoges, France

Location

University Hospital Poitiers

Poitiers, 86000, France

Location

Related Publications (2)

• Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.

  PMID: 31511996 BACKGROUND

• Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.

  PMID: 34649974 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: November 1, 2019
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (3)