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
1 other identifier
interventional
50
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Jan 2024
Shorter than P25 for not_applicable coronary-artery-disease
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
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedJanuary 17, 2024
January 1, 2024
3 months
October 22, 2023
January 13, 2024
Conditions
Keywords
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 COMPARATORRecord of CO/CI/SVR before and after weaning form ECC from radial and femoral artery cannula.
Hypotension event
ACTIVE COMPARATORPrevent of hypotension event calculated from radial/femoral artery cannula
Interventions
fluctuations of CO/CI/SVR regarding data from radial or femoral arterial cannula, and the therapeutic intervention that it demands these values.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Olga Ananiadou, MD,PhD
George PAPANIKOLAOU G.H.
Central Study Contacts
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