Back to resultsHeart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
Primary Purpose
Cardiac Arrhythmia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dataq Instruments DI-158
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrhythmia
Eligibility Criteria
Inclusion Criteria:
- All patients who will have cardiac surgery
- The patient must be mentally able and willing to participate in the study
- Male or female patients over the age of 18
Exclusion Criteria:
- Patients with major renal, hepatic, respiratory, or cerebral dysfunction
- Patients with atrial fibrillation or other forms of sinus node dysfunction
- Patients requiring continuous artificial pacing
- Patients with significant congenital heart disease with or without arrhythmias
- Patients on Intra-Aortic Balloon Pump
- Patients experiencing cardiac emergencies or undergoing cardiac salvage operations
Sites / Locations
- Hahnemann University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
This is a prospective observational study. 100 patients in one arm scheduled for cardiac surgery will be enrolled. ECG tracings will be obtained when subject is at rest, in supine position, before induction of anesthesia (within 24 hours prior to induction), after induction of general anesthesia, right before emergence from anesthesia (or before transportation to the ICU if the subject remains intubated), and within 24 hours post-operatively; additional ECG readings may be obtained during the surgery if deemed necessary.
Outcomes
Primary Outcome Measures
Investigate non-linear heart rate variability (HRV) indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.
Secondary Outcome Measures
Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively.
Full Information
NCT ID
NCT01359683
First Posted
April 7, 2008
Last Updated
June 12, 2013
Sponsor
Drexel University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01359683
Brief Title
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
Official Title
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Withdrawn
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate non-linear heart rate variability indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
This is a prospective observational study. 100 patients in one arm scheduled for cardiac surgery will be enrolled. ECG tracings will be obtained when subject is at rest, in supine position, before induction of anesthesia (within 24 hours prior to induction), after induction of general anesthesia, right before emergence from anesthesia (or before transportation to the ICU if the subject remains intubated), and within 24 hours post-operatively; additional ECG readings may be obtained during the surgery if deemed necessary.
Intervention Type
Device
Intervention Name(s)
Dataq Instruments DI-158
Intervention Description
Data Acquisition Device (connects to room instrumentation)
Primary Outcome Measure Information:
Title
Investigate non-linear heart rate variability (HRV) indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.
Time Frame
Sept 07 - Sept 08
Secondary Outcome Measure Information:
Title
Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively.
Time Frame
Sept 07 - Sept 08
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who will have cardiac surgery
The patient must be mentally able and willing to participate in the study
Male or female patients over the age of 18
Exclusion Criteria:
Patients with major renal, hepatic, respiratory, or cerebral dysfunction
Patients with atrial fibrillation or other forms of sinus node dysfunction
Patients requiring continuous artificial pacing
Patients with significant congenital heart disease with or without arrhythmias
Patients on Intra-Aortic Balloon Pump
Patients experiencing cardiac emergencies or undergoing cardiac salvage operations
Facility Information:
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
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