- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060926
Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning (Intub_prone)
June 2, 2022 updated by: Piquilloud Imboden Lise, University of Lausanne Hospitals
Intubation Prediction in Sars-CoV-2 Patients Treated With Awake Prone Positioning
Retrospective study in Sars-Cov 2 patients hospitalised in ICU.
We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
42
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
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- Lausanne University Hospitals
-
-
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
Sampling Method
Probability Sample
Study Population
Sars-CoV-2 pneumonia patients with severe hypoxemia
Description
Inclusion Criteria:
- Sars-CoV-2 pneumonia
- ICU stay
- Severe hypoxemia but non intubated
Exclusion Criteria:
- Intubated before admission
- Denied consent for data analysis
- Do not intubate order at ICU admission
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intubation rate
Time Frame: Once between ICU admission and extubation
|
Once between ICU admission and extubation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alveolo-arterial gradient change
Time Frame: Within 6 hours before and 6 hours after each pronation
|
Within 6 hours before and 6 hours after each pronation
|
Blood gas analysis
Time Frame: Within 6 hours before and 6 hours after each pronation
|
Within 6 hours before and 6 hours after each pronation
|
Respiratory pattern
Time Frame: Within 6 hours before and 6 hours after each pronation
|
Within 6 hours before and 6 hours after each pronation
|
Mortality
Time Frame: Up to 28 days from ICU admission
|
Up to 28 days from ICU admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 16, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
September 16, 2021
First Submitted That Met QC Criteria
September 27, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 2, 2022
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intub_prone
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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