Comparison of a New Semi-invasive Monitoring System With Transpulmonary Thermodilution in Cardiac Surgery Patients
Estimation of Cardiac Output by a New Semi-invasive Monitoring System: Accuracy and Limitations
1 other identifier
interventional
65
1 country
1
Brief Summary
The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. The investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedOctober 25, 2016
October 1, 2016
2.7 years
December 3, 2012
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cardiac output by pulse contour Analysis compared with transpulmonary thermodilution
plotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots
participants will be followed for the start and the end of operation, on the average of 4 hours
Study Arms (1)
COPFX
OTHERcardiac output by PulsioFlex® Monitoring system (COPFX)
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing elective coronary artery bypass grafting Personal declaration of consent to the study
You may not qualify if:
- Patients \<18 years of age A left ventricular ejection fraction ≤0.5 Emergency procedures Patients with haemodynamic instability requiring continuous pharmacologic support Patients with intracardiac shunts Severe aortic-, tricuspid- or mitral stenosis or insufficiency Mechanical circulatory support.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology and Intensive Care Medicine
Kiel, Schleswig-Holstein, 24105, Germany
Related Publications (1)
Broch O, Carbonell J, Ferrando C, Metzner M, Carstens A, Albrecht M, Gruenewald M, Hocker J, Soro M, Steinfath M, Renner J, Bein B. Accuracy of an autocalibrated pulse contour analysis in cardiac surgery patients: a bi-center clinical trial. BMC Anesthesiol. 2015 Nov 26;15:171. doi: 10.1186/s12871-015-0153-2.
PMID: 26612072DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Berthold Bein, Professor
University Schleswig-Holstein, Campus Kiel, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ole Broch M.D.
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 9, 2014
Study Start
March 1, 2012
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
October 25, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share