Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

Not Applicable

Withdrawn

• Conditions: Cardiac Arrhythmia
• Interventions: Device: Dataq Instruments DI-158

• Registration Number: NCT01359683
• Lead Sponsor: Drexel University College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2008-04
• Study First Submitted: 2008-04-07
• Primary Completion: 2009-09
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Dataq Instruments DI-158	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.

Primary Outcome Measures

Name	Time	Method
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.	Sept 07 - Sept 08

Secondary Outcome Measures

Name	Time	Method
Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively.	Sept 07 - Sept 08

Trial Locations

Locations (1)

Hahnemann University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States