Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of Continuously Determined Transcutaneous Carbon Dioxide Partial Pressures in Patients Supported With Veno-arterial Extracorporeal Membrane Oxygenation

Conditions
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Carbon Dioxide

Intervention / Treatment
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* Device: VA-ECMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low cardiac output requiring VA-ECMO support. Exclusion Criteria: Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VA-ECMO patients<br>VA-ECMO support because of low cardiac output. | Device: VA-ECMO<br>* Deployment of extracorporeal membrane oxygenation cardiac assist device.<br>|

What is the study measuring?
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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. | 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 | 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. | 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 | Pearson correlation, Concordance analysis | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, Carbon dioxide elimination, Organ perfusion, Low cardiac output, Monitoring, Critical Care