Perioperative Management of Patients With Pacemakers

June 3, 2018 updated by: Yong Seog Oh
Traditionally, when a patient who received permanent pacemaker undergoes surgery, physicians change pacemaker mode to DDD and recommend to use bipolar electrocautery to minimize electromagnetic interference. However, pacemaker function is improving and there's diverse suggestions for such situations. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in case group and VOO is applied before surgery in control group. Perioperative adverse event would be compared in both groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It has been more than 50 years after pacemaker device is developed. The subjects receiving permanent pacemaker has been increased and the number of patients with pacemaker undergoing surgery has been increased in company. However, in cases using electrocautery during surgery, there is possibility of malfunction of pacemaker due to electromagnetic interference. The factors associated with pacemaker malfunction during surgery have been reported; type of pacemaker, intrinsic heart rate, pacemaker dependency, type of electrocautery, position of generator, distance between generator/lead and electrocautery, duration and power of electrical energy. Conventionally, mode change to VOO before surgery and use of bipolar electrocautery are recommended before surgery but diverse suggestions regarding perioperative pacemaker mode change has been raised. The investigators aimed to contemplate the necessity of perioperative pacemaker mode change by prospective randomized trial. Patients with permanent pacemaker undergoing surgery are randomized into two groups by 1:1 ratio. No mode change is applied before surgery in the case group and VOO mode is applied before surgery in the control group. Exclusion criteria is thoracic surgery, 100% pacemaker dependency and unipolar pacing. The investigators will compare perioperative adverse events. The primary endpoint is asystole and the secondary endpoint is cardiac arrest, pacing inhibition, torsades de pointes and R on T.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seo Ch-gu
      • Seoul, Seo Ch-gu, Korea, Republic of, 137-701
        • Recruiting
        • Seoul St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • over 19 years old Patients undergoing surgery using electrocautery who received permanent pacemaker

Exclusion Criteria:

  • Thoracic surgery (lung, esophagus, heart, breast) Totally pacemaker dependent patient. Unipolar pacing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: No change group
Case management consists keeping patient's current pacemaker mode during surgery
Device: Case management
Case management consists keeping patient's current pacemaker mode during surgery
No Intervention: Control: Mode change group
Usual care consists changing pacemaker mode to VOO before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of asystole
Time Frame: Perioperative period
Perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yong Seog Oh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

June 3, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 3, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • periop pacemaker

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preoperative State

Clinical Trials on Case management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe