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NCT Number: NCT04445909

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

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.

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Key information

Conditions

Carbon Dioxide Cardiac Output, Low Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Low cardiac output requiring VA-ECMO support.

Exclusion criteria

  • Age < 18 years

Treatment and study plan

VA-ECMO

Device

Deployment of extracorporeal membrane oxygenation cardiac assist device.

Primary outcomes

  1. Agreement between transcutaneous carbon dioxide partial pressure measurement and arterial carbon dioxide partial pressures in VA-ECMO patients.

    Time frame: Through study completion, an average of 2 years

    Bland Altman plot, Pearson correlation, Concordance analysis

Secondary outcomes

  1. Reaction time from attachment of sensor to first reliable reading and its modifiers

    Time frame: Through study completion, an average of 2 years

    Descriptive statistics

  2. Agreement between transcutaneous oxygen partial pressure measurement and arterial oxygen partial pressures in VA-ECMO patients.

    Time frame: Through study completion, an average of 2 years

    Bland Altman plot, Pearson correlation, Concordance analysis

  3. Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation

    Time frame: Through study completion, an average of 2 years

    Pearson correlation, Concordance analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Dworschak, MD, MBA

CONTACT

[email protected]

+43-1-40400 ext. 41090

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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