Monitoring of Cardiac Function With 3-axis Accelerometers

Completed

• Conditions: Heart; Surgery, Heart, Functional Disturbance as Result

• Registration Number: NCT01926067
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-19
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-20
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics.	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.

Trial Locations

Locations (1)

Oslo University Hospital, The Intervention Sentre; 🇳🇴 Oslo, Norway