NCT01572246

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 167 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure
• Tachycardia, Ventricular

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-09-14
• Completion: 2016-09-14
• First posted: 2012-04-06
• Last updated: 2017-02-24

Locations

1 site across 1 country: United States