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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0027
    • Oslo University Hospital, The Intervention Sentre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with significant aortic stenosis scheduled for surgical AVR

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Study Director: Erik Fosse, Professor, Oslo University Hospital, The Intervention Sentre

Publications and helpful links

General Publications

• Grymyr OH, Beitnes JO, Eidet J, Tollofsrud S, Fiane A, Skulstad H, Fosse E, Halvorsen PS. Detection of intraoperative myocardial dysfunction by accelerometer during aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Feb 1;24(2):188-195. doi: 10.1093/icvts/ivw326.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (ESTIMATE): August 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 27, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Accelerometer; Cardiopulmonary by pass
• Other Study ID Numbers: 2011/2305 A (REK)