- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123940
Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy (WIN IN WEAN)
February 19, 2019 updated by: University Hospital, Clermont-Ferrand
Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
Study Type
Interventional
Enrollment (Actual)
483
Phase
- Phase 3
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
-
-
-
Clermont-Ferrand, France, 63003
- CHU de Clermont-Ferrand
-
-
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:
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Exclusion Criteria:
- severe COBP
- Laryngeal dyspnea
- Tracheostomy
- Arrhythmia
- No echogenicity
- Paraplegia >T8
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 |
---|---|
Experimental: nasal humidified high flow therapy
Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
|
Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
|
Other: standard strategy
Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
|
Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postextubation distress
Time Frame: during 48 hour (at day 1)
|
postextubation period requiring a ventilatory support (reintubation or curative Noninvasive ventilation).
|
during 48 hour (at day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay in ICU
Time Frame: at day 1
|
at day 1
|
|
Number of ventilator-free-days
Time Frame: at day 1 (after extubation)
|
at day 1 (after extubation)
|
|
Mortality in ICU
Time Frame: at day 1
|
at day 1
|
|
Extubation failure
Time Frame: at day 7
|
Extubation failure within the 7 days following planned extubation
|
at day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 1, 2014
Primary Completion (Actual)
August 25, 2018
Study Completion (Actual)
August 25, 2018
Study Registration Dates
First Submitted
April 11, 2014
First Submitted That Met QC Criteria
April 24, 2014
First Posted (Estimate)
April 28, 2014
Study Record Updates
Last Update Posted (Actual)
February 20, 2019
Last Update Submitted That Met QC Criteria
February 19, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU-0187
- 2013-A01458-37
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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