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

NCT01359683 | Withdrawn

• 1 other identifier: 17028
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

A

OTHER

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.

Device: Dataq Instruments DI-158

Interventions

Dataq Instruments DI-158 DEVICE

Data Acquisition Device (connects to room instrumentation)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University College of Medicine: lead

Study Sites (1)

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: May 25, 2011
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Last Updated: June 14, 2013

Record last verified: 2008-04

Locations

US (1)