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

March 11, 2019 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • CHU Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reintubation at Day 7
Time Frame: up to 7 days
The rate of reintubation will be assessed within the 7 days following planned extubation
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Arnaud W THILLE, CHU Poitiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

April 17, 2018

Study Completion (Actual)

April 17, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIGH-WEAN Study
  • 2016-A01078-43 (Other Identifier: CPP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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