Perioperative Management of Patients With Pacemakers

NCT ID: NCT03556241

Last Updated: 2018-06-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preoperative State Presence of Pacemaker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention: No change group

Case management consists keeping patient's current pacemaker mode during surgery

Group Type EXPERIMENTAL

Case management

Intervention Type DEVICE

Case management consists keeping patient's current pacemaker mode during surgery

Control: Mode change group

Usual care consists changing pacemaker mode to VOO before surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Case management

Case management consists keeping patient's current pacemaker mode during surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yong-Seog Oh, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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Seoul St Mary's Hospital

Seoul, Seo Ch-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong-Seog Oh, MD,PhD

Role: CONTACT

82-2-2258-6035

Ju Youn Kim, MD

Role: CONTACT

82-10-5482-7307

Facility Contacts

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Ju Youn Kim, MD

Role: primary

82-10-5482-7307

Other Identifiers

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periop pacemaker

Identifier Type: -

Identifier Source: org_study_id

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