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

Carbon Dioxide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445909
• Other study ID #: 456499
• Status: Recruiting
• Start date: November 18, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2023
• Source: Medical University of Vienna
• Contact: Martin Dworschak, MD, MBA
• Phone: +43-1-40400
• Email: martin.dworschak[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Low cardiac output requiring VA-ECMO support.

Exclusion Criteria:

• Age < 18 years

Related Conditions & MeSH terms

• Carbon Dioxide

Intervention

Device:
• VA-ECMO
Deployment of extracorporeal membrane oxygenation cardiac assist device.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reaction time from attachment of sensor to first reliable reading and its modifiers	Descriptive statistics	Through study completion, an average of 2 years
Secondary	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
Secondary	Correlation between transcutaneous carbon dioxide partial pressure level and brain saturation	Pearson correlation, Concordance analysis	Through study completion, an average of 2 years