Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
ConditionCarbon Dioxide
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Low cardiac output requiring VA-ECMO support.
Disqualifiers
Age < 18 years
Trial population
Patients with low cardiac output after ECMO deployment in tertiary care center.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
VA-ECMO
DeviceDeployment of extracorporeal membrane oxygenation cardiac assist device.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VA-ECMO patients1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Reaction time from attachment of sensor to first reliable reading and its modifiers
Descriptive statistics
Time frame
Through study completion, an average of 2 years2
Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.
Bland Altman plot, Pearson correlation, Concordance analysis
Time frame
Through study completion, an average of 2 years3
Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation
Pearson correlation, Concordance analysis
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov