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

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.

Study Overview

• Status: Recruiting
• Conditions: Carbon Dioxide
• Intervention / Treatment: Device: VA-ECMO

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Martin Dworschak, MD, MBA; Phone Number: 41090 +43-1-40400; Email: martin.dworschak@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Martin Dworschak, MD, MBA; Phone Number: 41090 +43-1-40400; Email: martin.dworschak@meduniwien.ac.at
    • Contact: Martin Bernardi, MD; Phone Number: 64100 +43-1-40400; Email: martin.bernardi@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with low cardiac output after ECMO deployment in tertiary care center.

Description

Inclusion Criteria:

• Low cardiac output requiring VA-ECMO support.

Exclusion Criteria:

• Age < 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VA-ECMO patients; VA-ECMO support because of low cardiac output.	Device: VA-ECMO; Deployment of extracorporeal membrane oxygenation cardiac assist device.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Martin Dworschak, MD, MBA, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Monitoring; ECMO; Critical Care; Carbon dioxide elimination; Organ perfusion; Low cardiac output
• Other Study ID Numbers: 456499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No