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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03121482
Recruitment Status : Completed
First Posted : April 20, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Requiring Reintubation Device: HFNC Device: NIV Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

Arm Intervention/treatment
Active Comparator: HFNC alone
Control group
Device: HFNC
Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%

Experimental: HFNC and NIV Device: HFNC
Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%

Device: NIV
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%




Primary Outcome Measures :
  1. Reintubation at Day 7 [ Time Frame: up to 7 days ]
    The rate of reintubation will be assessed within the 7 days following planned extubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121482


Locations
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France
CHU Poitiers
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Arnaud W THILLE CHU Poitiers

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03121482     History of Changes
Other Study ID Numbers: HIGH-WEAN Study
2016-A01078-43 ( Other Identifier: CPP )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases