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Clinical Trials/NCT03121482
NCT03121482
Completed
Not Applicable

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

Poitiers University Hospital1 site in 1 country650 target enrollmentApril 20, 2017
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ConditionsAcute Respiratory Failure Requiring Reintubation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Failure Requiring Reintubation
Sponsor
Poitiers University Hospital
Enrollment
650
Locations
1
Primary Endpoint
Reintubation at Day 7
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2017
End Date
April 17, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Reintubation at Day 7

Time Frame: up to 7 days

The rate of reintubation will be assessed within the 7 days following planned extubation

Study Sites (1)

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