- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112561
Cardiac Index, SVR/SVRI During Weaning From ECC- Data Obtained From Femoral and Radial Artery Transducer (RaFe)
Fluctuation and Realbility of Cardiac Index and SVR/SVRI During Weaning From ECC Regarding Values Obtained From Femoral and Radial Artery Acumen IQ Sensor
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Irene Asouhidou, MD,PhD
- Phone Number: 00306944740633
- Email: iasouh@aol.com
Study Contact Backup
- Name: Theodoros Karaiskos, MD,PhD
- Email: theokaraiskos@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: Coronary artery disease , aortic valve stenosis, aortic valve regurgitation, mitral valve stenosis, mitral valve regurgitation,
Exclusion Criteria: none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cardiac output/index/SVR
Record of CO/CI/SVR before and after weaning form ECC from radial and femoral artery cannula.
|
fluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values.
|
Active Comparator: Hypotension event
Prevent of hypotension event calculated from radial/femoral artery cannula
|
fluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac output
Time Frame: 5 minutes after weaning from extracorporeal circulation (ECC)
|
Measurement of cardiac output from radial and femoral arterial cannula
|
5 minutes after weaning from extracorporeal circulation (ECC)
|
Prediction of hypotension episode (HPI)
Time Frame: 5 minutes after weaning from ECC
|
Measurement of possibility of hypotension episode (HPI) from femoral and radial arterial cannula
|
5 minutes after weaning from ECC
|
Systemic Vascular resistance (SVR)
Time Frame: 5 minutes after weaning from ECC
|
Measurement of SVR from femoral and radial arterial cannula
|
5 minutes after weaning from ECC
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Olga Ananiadou, MD,PhD, George PAPANIKOLAOU G.H.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aqumen23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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