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Monitoring of Cardiac Function With 3-axis Accelerometers

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ClinicalTrials.gov Identifier: NCT01926067
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : March 2, 2015
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital

Tracking Information
First Submitted Date June 19, 2012
First Posted Date August 20, 2013
Last Update Posted Date March 2, 2015
Study Start Date June 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monitoring of Cardiac Function With 3-axis Accelerometers
Official Title Monitoring of Cardiac Function With 3-axis Accelerometers During Weaning of Cardiopulmonary by Pass After Heart Surgery
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with significant aortic stenosis scheduled for surgical AVR
Condition Heart; Surgery, Heart, Functional Disturbance as Result
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Grymyr OH, Beitnes JO, Eidet J, Tølløfsrud 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2013)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01926067
Other Study ID Numbers 2011/2305 A (REK)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators University of Oslo
Investigators
Study Director: Erik Fosse, Professor Oslo University Hospital, The Intervention Sentre
PRS Account Oslo University Hospital
Verification Date February 2015