Skip to main content
OpenTrials
Completed

NCT Number: NCT01572246

Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Arrhythmias, Cardiac Body Temperature Changes Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heat Stress Disorders Hyperthermia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Tachycardia Tachycardia, Ventricular Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult individuals of both genders, 18 years of age and older
  • For patients undergoing surgery about the waist, previous implantation of a functioning Boston Scientific or Medtronic ICD
  • For patients undergoing surgery below the waist, previous implantation of a functioning Boston Scientific, Medtronic, St. Jude Medical, or Biotronik ICD
  • Signed informed consent

Exclusion criteria

  • Surgery involving the ICD pocket (generator change out procedure)
  • Surgery or procedures exclusively involving bipolar electrocautery (such as ophthalmic surgery)
  • Patients undergoing surgery above the waist with ICDs not manufactured by Medtronic or Boston Scientific (other ICDs do not allow reprogramming to allow EMI detection without the potential for inadvertent ICD discharge)

Treatment and study plan

Optimal placement of return pad

Other

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

Primary outcomes

  1. Incidence of electromagnetic interference (EMI)

    Time frame: During surgery on day of enrollment

    Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD.

Secondary outcomes

  1. Incidence of unexpected preoperative ICD-related problems

    Time frame: Up to 6 months prior to date of surgery

    Determine the incidence and nature of unexpected preoperative ICD-related problems, such as inadequate pacing or sensing thresholds, battery at or near elective replacement interval, and lead fracture, as detected by preoperative ICD interrogation.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.