- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920281
Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation (WEAN SLEEP 1)
January 12, 2018 updated by: Poitiers University Hospital
The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
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
-
-
-
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:
- Mechanical ventilation for at least 24 hours before the first weaning test
- difficult weaning of mechanical ventilation defined as failure to the first weaning test
- patients aged at least of 18 years
Exclusion Criteria:
- peripheral or central nervous system pathology
- known psychiatric pathology or agitation
- clinical worsening before polysomnography (shock with vasopressor drugs, coma with Glasgow scale < 8, PaO2/FiO2 ratio < 150 with respiratory distress signs)
- pregnant or breastfeeding women
- patient under legal guardianship or protection
- patient with no health insurance coverage
- age < 18 years
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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the length of weaning patients who have a poor quality of sleep to those who have a good quality sleep.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
November 1, 2014
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
September 29, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Actual)
January 17, 2018
Last Update Submitted That Met QC Criteria
January 12, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- WEAN SLEEP 1
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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