Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| VA-ECMO patients VA-ECMO support because of low cardiac output. |
Device: VA-ECMO
Deployment of extracorporeal membrane oxygenation cardiac assist device.
|
Outcome Measures
Primary Outcome Measures
- Agreement between transcutaneous carbon dioxide partial pressure measurement and arterial carbon dioxide partial pressures in VA-ECMO patients. [Through study completion, an average of 2 years]
Bland Altman plot, Pearson correlation, Concordance analysis
Secondary Outcome Measures
- Reaction time from attachment of sensor to first reliable reading and its modifiers [Through study completion, an average of 2 years]
Descriptive statistics
- Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients. [Through study completion, an average of 2 years]
Bland Altman plot, Pearson correlation, Concordance analysis
- Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation [Through study completion, an average of 2 years]
Pearson correlation, Concordance analysis
Eligibility Criteria
Criteria
Inclusion Criteria:
- Low cardiac output requiring VA-ECMO support.
Exclusion Criteria:
- Age < 18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Martin Dworschak, MD, MBA, Medical University of Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 456499