Monitoring of Cardiac Function With 3-axis Accelerometers

Heart; Surgery, Heart, Functional Disturbance as Result Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926067
• Other study ID #: 2011/2305 A (REK)
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: February 27, 2015
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result
• Pathologic Processes

Locations

Country	Name	City	State
Norway	Oslo University Hospital, The Intervention Sentre	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of global heart function measures between accelerometer, echocardiography and hemodynamics.	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.	The patients will be followed during surgery, approximately 3 hours.	No