Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
|ClinicalTrials.gov Identifier: NCT01572246|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : February 24, 2017
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 or disease||Intervention/treatment|
|Heart Failure Tachycardia, Ventricular||Other: Optimal placement of return pad|
|Study Type :||Observational|
|Actual Enrollment :||167 participants|
|Official Title:||Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||September 14, 2016|
|Actual Study Completion Date :||September 14, 2016|
U.S. FDA Resources
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.
Subjects with an implanted ICD who present for a cardiac surgical procedure involving monopolar electrocautery
Subjects with an implanted ICD who present for a below-the-waist surgical procedure involving monopolar electrocautery
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572246
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Peter Schulman, MD||Oregon Health and Science University|
|Principal Investigator:||Charles Henrikson, MD||Oregon Health and Science University|