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

Sponsor
George Papanicolaou Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06112561
Collaborator
(none)
50
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: CO/CI/SVR
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cardiac output [5min after weaning from extracorporeal circulation (ECC)]

    Measurement of cardiac output from radial and femoral arterial cannula

  2. Prediction of hypotension episode (HPI) [5min min after weaning from ECC]

    Measurement of possibility of hypotension episode (HPI) from femoral and radial arterial cannula

  3. Systemic Vascular resistance (SVR) [5min min after weaning from ECC]

    Measurement of SVR from femoral and radial arterial cannula

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria:all patients scheduled for elective surgery: coronary artery bypass graft (CABG), valve replacement (VR), combined CABG and VR.

-

Exclusion Criteria: previous surgery in femoral or iliac artery.

-

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • George Papanicolaou Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Asouhidou Irene, prof, George Papanicolaou Hospital
ClinicalTrials.gov Identifier:
NCT06112561
Other Study ID Numbers:
  • Aqumen23
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Asouhidou Irene, prof, George Papanicolaou Hospital
cardiac output
cardiac index
systemic vascular resistance
Additional relevant MeSH terms:
Coronary Artery Disease
Aortic Valve Disease

Study Results

No Results Posted as of Nov 1, 2023