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

January 13, 2024 updated by: Asouhidou Irene, George Papanicolaou Hospital

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

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Irene Asouhidou, MD,PhD
  • Phone Number: 00306944740633
  • Email: iasouh@aol.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Coronary artery disease , aortic valve stenosis, aortic valve regurgitation, mitral valve stenosis, mitral valve regurgitation,

Exclusion Criteria: none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
Active Comparator: Hypotension event
Prevent of hypotension event calculated from radial/femoral artery cannula
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

George Papanicolaou Hospital

Investigators

  • Study Chair: Olga Ananiadou, MD,PhD, George PAPANIKOLAOU G.H.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aqumen23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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