Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

This study is currently recruiting participants.
Verified November 2013 by Oregon Health and Science University
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Peter Schulman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01572246
First received: March 27, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Heart Failure
Tachycardia, Ventricular
Other: Optimal placement of return pad

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Incidence of electromagnetic interference (EMI) [ Time Frame: During surgery on day of enrollment ] [ Designated as safety issue: Yes ]
    Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD.


Secondary Outcome Measures:
  • Incidence of unexpected preoperative ICD-related problems [ Time Frame: Up to 6 months prior to date of surgery ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 350
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-cardiac above-the-waist surgery
Subjects with an implanted ICD who present for a non-cardiac above-the-waist surgical procedure involving monopolar electrocautery
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.
Cardiac surgery
Subjects with an implanted ICD who present for a cardiac surgical procedure involving monopolar electrocautery
Below-the-waist surgery
Subjects with an implanted ICD who present for a below-the-waist surgical procedure involving monopolar electrocautery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with ICDs (including cardiac resynchronization therapy system-defibrillators) scheduled for surgery involving ME.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572246

Contacts
Contact: Kathy Parker, MSN 503-494-5224 parkerk@ohsu.edu
Contact: Peter Schulman, MD 503-494-7641 schulman@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Peter Schulman, MD    503-494-7641      
Principal Investigator: Peter Schulman, MD         
Principal Investigator: Eric Stecker, MD         
Sponsors and Collaborators
Oregon Health and Science University
Boston Scientific Corporation
Investigators
Principal Investigator: Peter Schulman, MD Oregon Health and Science University
Principal Investigator: Eric Stecker, MD Oregon Health and Science University
  More Information

Publications:

Responsible Party: Peter Schulman, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01572246     History of Changes
Other Study ID Numbers: ISROTH20028
Study First Received: March 27, 2012
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
electrosurgery
Cardiac surgical procedures
Surgical procedures, operative
Defibrillators

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014