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

NCT ID: NCT04445909

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Carbon Dioxide

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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VA-ECMO patients

VA-ECMO support because of low cardiac output.

VA-ECMO

Intervention Type DEVICE

Deployment of extracorporeal membrane oxygenation cardiac assist device.

Interventions

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VA-ECMO

Deployment of extracorporeal membrane oxygenation cardiac assist device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Low cardiac output requiring VA-ECMO support.

Exclusion Criteria

* Age \< 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Martin Dworschak

Assoc. Prof. of Anesthesia and Intensive Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Dworschak, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Martin Dworschak, MD, MBA

Role: CONTACT

[email protected]
+43-1-40400 ext. 41090

Facility Contacts

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Martin Dworschak, MD, MBA

Role: primary

[email protected]
+43-1-40400 ext. 41090

Martin Bernardi, MD

Role: backup

[email protected]
+43-1-40400 ext. 64100

Other Identifiers

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456499

Identifier Type: -

Identifier Source: org_study_id