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NCT Number: NCT07030413

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Respiratory Failure With Hypoxia High-Flow Nasal Oxygen Therapy Respiration Disorders Respiratory Failure, ICU Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hospital-free days at day 90

    Time frame: 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 outcomes

  1. Duration of intensive care unit (ICU) stay

    Time frame: 90 days

    The number of days spent in the ICU

  2. ICU mortality

    Time frame: 90 days

    The number (and proportion) of patients who died in the ICU

  3. Survival at day 90

    Time frame: 90 days

    The number (and proportion) of patients alive at day 90 from pseudorandomization

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • University Hospital, Bordeaux
  • University Hospital, Limoges

Registry information

Official study title

Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation From Nouvelle-Aquitaine Health Data Warehouses

Acronym: HFNO-Weaning

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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