Monitoring of Cardiac Function With 3-axis Accelerometers
1 other identifier
observational
20
1 country
1
Brief Summary
Aim of the study: To validate accelerometers for continuous monitoring of global cardiac function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Shorter than P25 for all trials
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
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedMarch 2, 2015
February 1, 2015
10 months
June 19, 2012
February 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics.
Measures will be assessed at baseline before cardiopulmonary by pass, at different workloads during a stepwise weaning, and after the cannulas are removed. The accelerometer measurements will be compared to echocardiography and hemodynamics (stroke volume and cardiac output). Systolic global function will be assessed by comparing peak systolic velocity and displacement by the accelerometer and the corresponding findings in echocardiography. The accelerometer systolic measures will also be correlated to ejection fraction with echocardiography. Diastolic global function early inflow (E'), atrial inflow velocity (A') and E'/A' with accelerometers and echocardiography will be compared.
The patients will be followed during surgery, approximately 3 hours.
Eligibility Criteria
Patients with significant aortic stenosis scheduled for surgical AVR
You may qualify if:
- Significant aortic valvular disease scheduled to undergo cardiac surgery with an estimated extracorporeal circulation time \> 40 min.
You may not qualify if:
- Evolving myocardial infarction,
- dyskinetic wall motions,
- cardiogenic shock,
- hepatic dysfunction or esophageal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Oslo University Hospital, The Intervention Sentre
Oslo, 0027, Norway
Related Publications (1)
Grymyr OH, Beitnes JO, Eidet J, Tollofsrud S, Fiane A, Skulstad H, Fosse E, Halvorsen PS. Detection of intraoperative myocardial dysfunction by accelerometer during aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):188-195. doi: 10.1093/icvts/ivw326.
PMID: 28364479DERIVED
Study Officials
- STUDY DIRECTOR
Erik Fosse, Professor
Oslo University Hospital, The Intervention Sentre
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2012
First Posted
August 20, 2013
Study Start
June 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 2, 2015
Record last verified: 2015-02