- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816928
Ventilation-Perfusion Matching in Early-stage Prone Position Ventilation
April 17, 2023 updated by: Peking Union Medical College Hospital
Ventilation-Perfusion Matching in Early-stage Prone Position Ventilation: A Comparison Between COVID-19 ARDS and ARDS From Other Etiologies
Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS).
This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS from other etiologies (non-CARDS) using electrical impedance tomography (EIT).
Study Overview
Status
Completed
Conditions
Detailed Description
In this prospective study, both COVID19-associated ARDS (CARDS) patients and patients with ARDS from other etiologies (non-CARDS) were enrolled.
Electrical impedance tomography (EIT) was used to evaluate the changes in ventilation and perfusion between supine and prone positions.
Baseline values of the area of DeadSpace, shunt, ventilation-perfusion matching (VQmatch) were identified at the time of enrollment.
Within the defined VQmatch region, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region.
Prone position was applied immediately after the baseline data were collected.
After 2 hours of proning, another EIT examination was conducted.
Parameters such as DeadSpace, shunt, VQmatch, and other common measurements before and after pronation were taken and compared to evaluate the effect of prone positioning on CARDS and non-CARDS patients.
Study Type
Observational
Enrollment (Actual)
29
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
-
-
Beijing
-
Beijing, Beijing, China, 100730
- PUMC
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population includes COVID19-associated ARDS patients and ARDS patients of other etiologies in the intensive care unit.
Description
Inclusion Criteria:
- Above the age of 18
- Diagnosed with ARDS based on the Berlin Definition of ARDS
- Under mechanical ventilation
Exclusion Criteria:
- Contraindications to EIT examination and prone position
- Refusal of signing the informed consent
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
Cohorts and Interventions
Group / Cohort |
|---|
|
COVID19-associated ARDS (CARDS)
This group included COVID19 patients with acute respiratory distress syndrome.
Patients were put under prone position while their pulmonary function was measured using EIT before and after proning.
|
|
Non-COVID19-associated ARDS (non-CARDS)
This group included patients with acute respiratory distress syndrome from other etiologies.
Patients were put under prone position while their pulmonary function was measured using EIT before and after proning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DeadSpace
Time Frame: 3 months
|
The area of Deadspace will be assessed using electrical impedance tomography
|
3 months
|
|
Shunt
Time Frame: 3 months
|
Shunt will be assessed using electrical impedance tomography
|
3 months
|
|
Ventilation-perfusion matching (VQmatch)
Time Frame: 3 months
|
VQmatch will be assessed using electrical impedance tomography
|
3 months
|
|
Global inhomogeneity index (VQmatch-GI)
Time Frame: 3 months
|
Within the defined VQmatch region assessed by electrical impedance tomography, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventilation
Time Frame: 3 months
|
The ventilation of the lungs is assessed by electrical impedance tomography before and after prone positioning.
|
3 months
|
|
Perfusion
Time Frame: 3 months
|
The perfusion of the lungs is assessed by electrical impedance tomography before and after prone positioning.
|
3 months
|
|
Center of Ventilation (CoV)
Time Frame: 3 months
|
The center of ventilation of the lungs is assessed by electrical impedance tomography before and after prone positioning.
|
3 months
|
|
Standard deviation of regional ventilation delay
Time Frame: 3 months
|
The standard deviation of regional ventilation delay of the lungs is assessed by electrical impedance tomography before and after prone positioning.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yun Long, MD, Peking Union Medical College
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)
January 12, 2021
Primary Completion (Actual)
April 12, 2021
Study Completion (Actual)
April 12, 2021
Study Registration Dates
First Submitted
April 5, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 17, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EIT20230403
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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