Monitoring of Cardiac Function With 3-axis Accelerometers

Aim of the study: To validate accelerometers for continuous monitoring of global cardiac function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.

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Key information

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, The Intervention Sentre

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

University of Oslo

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 20, 2013
Registry last updated: Mar 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed