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

NCT ID: NCT01359683

Last Updated: 2013-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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Conditions

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Cardiac Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

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.

Group Type OTHER

Dataq Instruments DI-158

Intervention Type DEVICE

Data Acquisition Device (connects to room instrumentation)

Interventions

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Dataq Instruments DI-158

Data Acquisition Device (connects to room instrumentation)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Drexel University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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17028

Identifier Type: -

Identifier Source: org_study_id

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