NCT06112561

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable coronary-artery-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

October 22, 2023

Last Update Submit

January 13, 2024

Conditions

Keywords

cardiac outputcardiac indexsystemic vascular resistance

Outcome Measures

Primary Outcomes (3)

  • Cardiac output

    Measurement of cardiac output from radial and femoral arterial cannula

    5 minutes after weaning from extracorporeal circulation (ECC)

  • Prediction of hypotension episode (HPI)

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

    5 minutes after weaning from ECC

  • Systemic Vascular resistance (SVR)

    Measurement of SVR from femoral and radial arterial cannula

    5 minutes after weaning from ECC

Study Arms (2)

Cardiac output/index/SVR

ACTIVE COMPARATOR

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

Device: CO/CI/SVR

Hypotension event

ACTIVE COMPARATOR

Prevent of hypotension event calculated from radial/femoral artery cannula

Device: CO/CI/SVR

Interventions

CO/CI/SVRDEVICE

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

Cardiac output/index/SVRHypotension event

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseAortic Valve Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHeart Valve Diseases

Study Officials

  • Olga Ananiadou, MD,PhD

    George PAPANIKOLAOU G.H.

    STUDY CHAIR

Central Study Contacts

Irene Asouhidou, MD,PhD

CONTACT

Theodoros Karaiskos, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2023

First Posted

November 1, 2023

Study Start

January 1, 2024

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01