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Clinical Trials/NCT01926067
NCT01926067
Completed
Not Applicable

Monitoring of Cardiac Function With 3-axis Accelerometers During Weaning of Cardiopulmonary by Pass After Heart Surgery

Oslo University Hospital1 site in 1 country20 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart; Surgery, Heart, Functional Disturbance as Result
Sponsor
Oslo University Hospital
Enrollment
20
Locations
1
Primary Endpoint
Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics.
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
April 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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