Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators

Completed

Conditions studied: Heart Failure, Tachycardia, Ventricular

In brief

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.

Key facts

Study ID

NCT01572246

Run by

Oregon Health and Science University

People needed

167

Starts

2012-05-01

Expected to finish

2016-09-14

Last updated by the study team

2017-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.