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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04445909
Enrollment
30
Registered
2020-06-24
Start date
2019-11-18
Completion date
2025-12-31
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Dioxide

Keywords

ECMO, Carbon dioxide elimination, Organ perfusion, Low cardiac output, Monitoring, Critical Care

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.

Interventions

DEVICEVA-ECMO

Deployment of extracorporeal membrane oxygenation cardiac assist device.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Low cardiac output requiring VA-ECMO support.

Exclusion criteria

* Age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
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 yearsBland Altman plot, Pearson correlation, Concordance analysis

Secondary

MeasureTime frameDescription
Reaction time from attachment of sensor to first reliable reading and its modifiersThrough study completion, an average of 2 yearsDescriptive statistics
Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.Through study completion, an average of 2 yearsBland Altman plot, Pearson correlation, Concordance analysis
Correlation between transcutaneous carbon dioxide partial pressure level and brain saturationThrough study completion, an average of 2 yearsPearson correlation, Concordance analysis

Countries

Austria

Contacts

Primary ContactMartin Dworschak, MD, MBA
martin.dworschak@meduniwien.ac.at+43-1-40400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026