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NCT06112561 Clinical Trial

Cardiac Index, SVR/SVRI During Weaning From ECC- Data Obtained From Femoral and Radial Artery Transducer

Coronary Artery Disease Clinical Trial

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Official title:
Fluctuation and Realbility of Cardiac Index and SVR/SVRI During Weaning From ECC Regarding Values Obtained From Femoral and Radial Artery Acumen IQ Sensor

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06112561
Other study ID # Aqumen23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date May 2024

Study information
Verified date January 2024
Source George Papanicolaou Hospital
Contact Irene Asouhidou, MD,PhD
Phone 00306944740633
Email iasouh@aol.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Swan Ganz catheter-Edwards Lifesciences obtains values of cardiac output/index and systemic vascular resistance/index using the mean artery pressure of either radial or femoral artery. During weaning from extracorporeal circulation, arterial waveform-derived cardiac output measurements from radial cannulation site is not reliable as compared with measurements obtained from femoral cannulation site.

Description:

50 consecutive cardiac surgical patients undergoing on-pump primary coronary artery bypass, valve replacement or combined surgery are included in the study. Cardiac output is measured sequentially by the arterial pressure waveform analysis method from radial and femoral arterial sites

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date May 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Coronary artery disease , aortic valve stenosis, aortic valve regurgitation, mitral valve stenosis, mitral valve regurgitation, Exclusion Criteria: none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CO/CI/SVR
fluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
George Papanicolaou Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac output Measurement of cardiac output from radial and femoral arterial cannula 5 minutes after weaning from extracorporeal circulation (ECC)
Primary Prediction of hypotension episode (HPI) Measurement of possibility of hypotension episode (HPI) from femoral and radial arterial cannula 5 minutes after weaning from ECC
Primary Systemic Vascular resistance (SVR) Measurement of SVR from femoral and radial arterial cannula 5 minutes after weaning from ECC
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