MedPath

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

Recruiting
Conditions
Carbon Dioxide
Interventions
Device: VA-ECMO
Registration Number
NCT04445909
Lead Sponsor
Medical University of Vienna
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Low cardiac output requiring VA-ECMO support.
Read More
Exclusion Criteria
  • Age < 18 years
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
VA-ECMO patientsVA-ECMOVA-ECMO support because of low cardiac output.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Reaction time from attachment of sensor to first reliable reading and its modifiersThrough study completion, an average of 2 years

Descriptive statistics

Correlation between transcutaneous carbon dioxide partial pressure level and brain saturationThrough study completion, an average of 2 years

Pearson correlation, Concordance analysis

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

Trial Locations

Locations (1)

Medical University of Vienna

🇦🇹

Vienna, Austria

© Copyright 2025. All Rights Reserved by MedPath