Clinical trial NCT04445909: Validation of Continuous Transcutaneous Carbon Dioxide Monitoring in VA-ECMO Patients
Official title: Validation of Continuously Determined Transcutaneous Carbon Dioxide Partial Pressures in Patients Supported with Veno-arterial Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carbon Dioxide
Keywords: ECMO
Carbon dioxide elimination
Organ perfusion
Low cardiac output
Monitoring
Critical Care
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low cardiac output after ECMO deployment in tertiary care center.

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.

Eligibility criteria: Inclusion Criteria:

* Low cardiac output requiring VA-ECMO support.

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Agreement between transcutaneous carbon dioxide partial pressure measurement and arterial carbon dioxide partial pressures in VA-ECMO patients.
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Reaction time from attachment of sensor to first reliable reading and its modifiers
timeFrame: Through study completion, an average of 2 years
measure: Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.
timeFrame: Through study completion, an average of 2 years
measure: Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin Dworschak, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: