Monitoring of Cardiac Function With 3-axis Accelerometers
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ClinicalTrials.gov Identifier: NCT01926067 |
Recruitment Status :
Completed
First Posted : August 20, 2013
Last Update Posted : March 2, 2015
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Condition or disease |
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Heart; Surgery, Heart, Functional Disturbance as Result |
Hypothesis:
The following hypothesis will be tested: Accelerometer measures are clinical relevant indices of global left and right myocardial performance during weaning from cardiopulmonary bypass.
Model:
The performance of the accelerometer will be tested in a intraoperative setting, during weaning from cardiopulmonary bypass. Accelerometer measures of ventricular systolic and diastolic function will be compared to corresponding measures and indices of ventricular functions by echocardiography and hemodynamic monitoring during a step wise controlled weaning from cardiopulmonary bypass, ensuring precise control of pre- and afterload.
Study Type : | Observational |
Actual Enrollment : | 20 participants |
Time Perspective: | Prospective |
Official Title: | Monitoring of Cardiac Function With 3-axis Accelerometers During Weaning of Cardiopulmonary by Pass After Heart Surgery |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |
- Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics. [ Time Frame: The patients will be followed during surgery, approximately 3 hours. ]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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The hypothesis will be tested in 20 elective patients.
Inclusion Criteria:
- Significant aortic valvular disease scheduled to undergo cardiac surgery with an estimated extracorporeal circulation time > 40 min.
Exclusion Criteria:
- Evolving myocardial infarction,
- dyskinetic wall motions,
- cardiogenic shock,
- hepatic dysfunction or esophageal disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926067
Norway | |
Oslo University Hospital, The Intervention Sentre | |
Oslo, Norway, 0027 |
Study Director: | Erik Fosse, Professor | Oslo University Hospital, The Intervention Sentre |
Responsible Party: | Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT01926067 |
Other Study ID Numbers: |
2011/2305 A (REK) |
First Posted: | August 20, 2013 Key Record Dates |
Last Update Posted: | March 2, 2015 |
Last Verified: | February 2015 |
Accelerometer Cardiopulmonary by pass |