Monitoring of Cardiac Function With 3-axis Accelerometers

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01926067

Enrollment

Registered

2013-08-20

Start date

2012-06-30

Completion date

2013-04-30

Last updated

2015-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Keywords

Accelerometer, Cardiopulmonary by pass

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Norway

Outcome results