Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 5, 2014
Last verified: September 2014

March 27, 2012
September 5, 2014
May 2012
March 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01572246 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
March 2016
March 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Lisa Voltolina, MS 503-494-5224 voltolin@ohsu.edu
Contact: Peter Schulman, MD 503-494-7641 schulman@ohsu.edu
United States
 
NCT01572246
ISROTH20028
No
Peter Schulman, Oregon Health and Science University
Oregon Health and Science University
Boston Scientific Corporation
Principal Investigator: Peter Schulman, MD Oregon Health and Science University
Principal Investigator: Eric Stecker, MD Oregon Health and Science University
Oregon Health and Science University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP