High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period (HIGH-WEAN)

Poitiers University Hospital

Status: Completed

Conditions: Acute Respiratory Failure Requiring Reintubation

Treatments: Device: NIV; Device: HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT03121482

HIGH-WEAN Study

2016-A01078-43 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

HFNC alone

Active Comparator group

Description:

Control group

Treatment:

Device: HFNC

HFNC and NIV

Experimental group

Treatment:

Device: NIV

Device: HFNC