MedTrace Logo

Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

NCT01572246 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 167

Last updated 2017-02-24

No results posted yet for this study

Summary

This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will be used to prevent patients from receiving inadvertent shocks. This requires the presence of someone trained in ICD programming, but a trained person is not always readily available.

In this study the investigators will reprogram ICDs prior to surgery according to current practice, but will also record what would have happened had the ICD reprogramming not occurred ("detection on" but "therapy off"). In addition, the investigators will evaluate the effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI. The investigators hypothesize that directing the current return path away from the ICD will result in lower EMI rates than previously described.

Conditions

Interventions

OTHER

Optimal placement of return pad

The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Peter Schulman, MD · Oregon Health and Science University

  • Charles Henrikson, MD · Oregon Health and Science University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-09-14
Completion
2016-09-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01572246 on ClinicalTrials.gov