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Weaning protocol for high-flow nasal oxygen therapy in the ICU - Multicenter randomized controlled trial. HiFloWEAN

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504366-36-00
Acronym
DR230001
Enrollment
370
Registered
2023-09-19
Start date
2024-02-17
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

de novo acute respiratory failure

Brief summary

The primary endpoint was the success rate at D7, with success defined as "definitive" weaning from high-flow nasal oxygen therapy, i.e. patients weaned for more than 48 hours from high-flow nasal oxygen therapy without recourse to non-invasive ventilation or intubation and alive at D7.

Detailed description

Weaning rate from high-flow nasal oxygen therapy at D28, Time to definitive weaning from high-flow nasal oxygen therapy between randomization and D28, Cumulative incidence of intubation up to D28, Cumulative incidence of curative non-invasive ventilation up to D28, Mortality rate at D28, Number of days on high-flow nasal oxygen therapy in patients permanently weaned from high-flow nasal oxygen therapy between randomization and discharge from intensive care or at D28, Evolution of ROX index during weaning phase, Evolution of accessory respiratory muscle engagement by Patrick score, Progression of dyspnoea assessed by the modified Borg scale, Length of stay in intensive care and/or continuous care unit, Duration of stay between admission to the intensive care and/or continuous monitoring unit and discharge from intensive care OR the ability to be discharged from intensive care assessed through an aptitude assessment grid. The ability to be discharged from intensive care/continuous monitoring will be defined by the validation of all items on the modified aptitude assessment grid (see appendix).

Interventions

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint was the success rate at D7, with success defined as "definitive" weaning from high-flow nasal oxygen therapy, i.e. patients weaned for more than 48 hours from high-flow nasal oxygen therapy without recourse to non-invasive ventilation or intubation and alive at D7.

Secondary

MeasureTime frame
Weaning rate from high-flow nasal oxygen therapy at D28, Time to definitive weaning from high-flow nasal oxygen therapy between randomization and D28, Cumulative incidence of intubation up to D28, Cumulative incidence of curative non-invasive ventilation up to D28, Mortality rate at D28, Number of days on high-flow nasal oxygen therapy in patients permanently weaned from high-flow nasal oxygen therapy between randomization and discharge from intensive care or at D28, Evolution of ROX index during weaning phase, Evolution of accessory respiratory muscle engagement by Patrick score, Progression of dyspnoea assessed by the modified Borg scale, Length of stay in intensive care and/or continuous care unit, Duration of stay between admission to the intensive care and/or continuous monitoring unit and discharge from intensive care OR the ability to be discharged from intensive care assessed through an aptitude assessment grid. The ability to be discharged from intensive care/continuous monito

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026