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

NCT ID: NCT06112561

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Cardiac output/index/SVR

Record of CO/CI/SVR before and after weaning form ECC from radial and femoral artery cannula.

Group Type ACTIVE_COMPARATOR

CO/CI/SVR

Intervention Type DEVICE

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

Hypotension event

Prevent of hypotension event calculated from radial/femoral artery cannula

Group Type ACTIVE_COMPARATOR

CO/CI/SVR

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria: none
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Papanicolaou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asouhidou Irene

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olga Ananiadou, MD,PhD

Role: STUDY_CHAIR

George PAPANIKOLAOU G.H.

Central Contacts

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Irene Asouhidou, MD,PhD

Role: CONTACT

00306944740633

Theodoros Karaiskos, MD,PhD

Role: CONTACT

Other Identifiers

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Aqumen23

Identifier Type: -

Identifier Source: org_study_id

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