- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04445909
Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
March 13, 2023 updated by: Dr. Martin Dworschak, Medical University of Vienna
Validation of Continuously Determined Transcutaneous Carbon Dioxide Partial Pressures in Patients Supported With Veno-arterial Extracorporeal Membrane Oxygenation
Carbon dioxide in patients on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is eliminated via respirator as well as via the oxygenator's membrane of the ECMO machine.
Consequently, monitoring of end-tidal carbon dioxide tensions is limited, which can result in marked swings towards non-physiological values.
Hyper- and hypocapnia, however, can have detrimental effects on organ perfusion in a great number of patients supported with VA-ECMO.
Continuous, rapidly applicable monitoring of reliable carbon dioxide measures would therefore be extremely helpful to prevent harmful deviations from the norm.
The investigators therefore try to assess the accuracy and the precision of continuously measured non-invasive transcutaneous carbon dioxide partial pressures when compared with tensions determined by blood gas analysis.
Study Overview
Detailed Description
After documenting the characteristics of participants, cannulation site, and the cause for ECMO support, transcutaneous, arterial, venous, as well as end-tidal carbon dioxide partial pressure values are measured simultaneously at steady state conditions and compared with each other at various time points over a four-hour observation period.
In addition, oxygen tensions are registered transcutaneously and in arterial and venous blood while respirator settings, sweep gas flow, ECMO flow, body temperature, volume status, and the dosage of vasopressors are also being recorded.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Martin Dworschak, MD, MBA
- Phone Number: 41090 +43-1-40400
- Email: martin.dworschak@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
-
Contact:
- Martin Dworschak, MD, MBA
- Phone Number: 41090 +43-1-40400
- Email: martin.dworschak@meduniwien.ac.at
-
Contact:
- Martin Bernardi, MD
- Phone Number: 64100 +43-1-40400
- Email: martin.bernardi@meduniwien.ac.at
-
-
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 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with low cardiac output after ECMO deployment in tertiary care center.
Description
Inclusion Criteria:
- Low cardiac output requiring VA-ECMO support.
Exclusion Criteria:
- 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?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
VA-ECMO patients
VA-ECMO support because of low cardiac output.
|
Deployment of extracorporeal membrane oxygenation cardiac assist device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement between transcutaneous carbon dioxide partial pressure measurement and arterial carbon dioxide partial pressures in VA-ECMO patients.
Time Frame: Through study completion, an average of 2 years
|
Bland Altman plot, Pearson correlation, Concordance analysis
|
Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction time from attachment of sensor to first reliable reading and its modifiers
Time Frame: Through study completion, an average of 2 years
|
Descriptive statistics
|
Through study completion, an average of 2 years
|
Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.
Time Frame: Through study completion, an average of 2 years
|
Bland Altman plot, Pearson correlation, Concordance analysis
|
Through study completion, an average of 2 years
|
Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation
Time Frame: Through study completion, an average of 2 years
|
Pearson correlation, Concordance analysis
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Dworschak, MD, MBA, Medical University of Vienna
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)
November 18, 2019
Primary Completion (Anticipated)
July 31, 2023
Study Completion (Anticipated)
July 31, 2023
Study Registration Dates
First Submitted
May 23, 2020
First Submitted That Met QC Criteria
June 23, 2020
First Posted (Actual)
June 24, 2020
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 456499
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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