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NCT01572246 · ClinicalTrials.gov registry record
Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
A clinical trial, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 167
- Enrollment target
NCT01572246 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 167 participants.
The verdict
NCT01572246 has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 167 participants
- Enrollment target
Study 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.
Interventions
- OTHER Optimal placement of return pad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-09-14 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572246
The ClinicalTrials.gov registry entry for NCT01572246 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Optimal placement of return pad is the first listed.
NCT01572246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01572246 about?
NCT01572246 is a clinical study titled "Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators". 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 c...
What is the current status of trial NCT01572246?
This trial is currently completed. The enrollment target is 167 participants. The study started on 2012-05. Estimated completion is 2016-09-14.
What interventions are being tested in trial NCT01572246?
The interventions under investigation include: Optimal placement of return pad (OTHER).
Who is sponsoring clinical trial NCT01572246?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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