- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05115526
PEEP Setting in COVID19-related ARDS
November 9, 2021 updated by: Central Hospital, Nancy, France
Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.
The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate.
Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled.
Patients were monitored by an esophageal catheter and a 32-electrode EIT device.
Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT.
Respiratory mechanics variables were recorded.
Study Type
Observational
Enrollment (Actual)
17
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
-
-
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Nancy, France
- Service de Réanimation Médicale, Hôpital Central
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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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive adult patients under mechanical ventilation following COVID19-ARDS
Description
Inclusion Criteria:
- COVID19-related ARDS under invasive mechanical ventilation
Exclusion Criteria:
- none
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: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Value of PEEP
Time Frame: a single determination, within 24-48 hours after mechanical ventilation initiation
|
different PEEP values obtained through using different methods
|
a single determination, within 24-48 hours after mechanical ventilation initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory mechanics
Time Frame: a single determination, within 24-48 hours after mechanical ventilation initiation
|
Respiratory mechanics (plateau pressure, driving pressure, compliance, mechanical power) following different PEEP settings
|
a single determination, within 24-48 hours after mechanical ventilation initiation
|
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)
March 1, 2021
Primary Completion (Actual)
March 15, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
October 15, 2021
First Submitted That Met QC Criteria
November 9, 2021
First Posted (Actual)
November 10, 2021
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
November 9, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021PI117
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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