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

NCT04445909 | Recruiting

• 1 other identifier: 456499
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Carbon Dioxide

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

• Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation

  Through study completion, an average of 2 years

Study Arms (1)

VA-ECMO patients

VA-ECMO support because of low cardiac output.

Device: VA-ECMO

Interventions

VA-ECMO DEVICE

Deployment of extracorporeal membrane oxygenation cardiac assist device.

VA-ECMO patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Low cardiac output requiring VA-ECMO support.

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Dworschak, MD, MBA

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Dworschak, MD, MBA

CONTACT

+43-1-40400; martin.dworschak@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. of Anesthesia and Intensive Care Medicine

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 24, 2020
• Study Start: November 18, 2019
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)