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High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03121482
Acronym
HIGH-WEAN
Enrollment
650
Registered
2017-04-20
Start date
2017-04-20
Completion date
2018-04-17
Last updated
2019-03-13

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

Conditions

Acute Respiratory Failure Requiring Reintubation

Brief summary

Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

Interventions

DEVICEHFNC

Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%

DEVICENIV

Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Duration of mechanical ventilation prior to extubation at least 24h * Planned extubation decided by the physician in charge of the patient after success of a weaning trial * Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.

Exclusion criteria

* Patient admitted for traumatic brain injury * Periphal neuromuscular disease as reason for intubation * Usual lon-term treatment with NIV for chronic desease * Usual lon-term treatment with CPAP for obstructive apneas syndrome * Contraindication to NIV * Unplanned extubation * Do-not-reintubated order at time of extubation * Terminal extubation for end of life * People under legal protection * Opposition to participate

Design outcomes

Primary

MeasureTime frameDescription
Reintubation at Day 7up to 7 daysThe rate of reintubation will be assessed within the 7 days following planned extubation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026