High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period
Not Applicable
Completed
- Conditions
- Acute Respiratory Failure Requiring Reintubation
- Interventions
- Device: HFNCDevice: NIV
- Registration Number
- NCT03121482
- Lead Sponsor
- Poitiers University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HFNC and NIV HFNC - HFNC alone HFNC Control group HFNC and NIV NIV -
- Primary Outcome Measures
Name Time Method Reintubation at Day 7 up to 7 days The rate of reintubation will be assessed within the 7 days following planned extubation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Poitiers
🇫🇷Poitiers, France