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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
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital

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.

Condition or disease
Heart; Surgery, Heart, Functional Disturbance as Result

Detailed Description:

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.

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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



Primary Outcome Measures :
  1. 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
Study Population
Patients with significant aortic stenosis scheduled for surgical AVR
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Norway
Oslo University Hospital, The Intervention Sentre
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Study Director: Erik Fosse, Professor Oslo University Hospital, The Intervention Sentre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Oslo University Hospital:
Accelerometer
Cardiopulmonary by pass