Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT01926067
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Cardiac Function With 3-axis Accelerometers
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Monitoring of Cardiac Function With 3-axis Accelerometers During Weaning of Cardiopulmonary by Pass After Heart Surgery
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: