Heart FailureNCT01572246
Effects of Monopolar Electrocautery Use During Surgery on Implanted Cardiac Defibrillators
An observational study of Heart Failure and Tachycardia, Ventricular, run by Oregon Health and Science University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Tachycardia, Ventricular
- What is being tested?
- Optimal placement of return pad
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 14 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with ICDs (including cardiac resynchronization therapy system-defibrillators) scheduled for surgery involving ME.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
- Conditions
- Heart Failure, Tachycardia, Ventricular
- Being tested
- Optimal placement of return pad
- Keywords
- electrosurgery, Cardiac surgical procedures, Surgical procedures, operative, Defibrillators
- Medical subject headings
- Heart Failure, Tachycardia, Ventricular, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal placement of return padOther
The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of electromagnetic interference (EMI)
Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD.
Measured: During surgery on day of enrollment
Secondary outcomes (1)
Incidence of unexpected preoperative ICD-related problems
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.
Measured: Up to 6 months prior to date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMay 2012
- Primary completion14 Sep 2016
- Study completion14 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Peter Schulman, Oregon Health and Science University
- Investigators
- Peter Schulman, MD, Principal investigator, Oregon Health and Science UniversityCharles Henrikson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572246
- Sponsor's protocol ID
- ISROTH20028
- Status last verified
- Aug 2016
- First submitted
- 27 Mar 2012
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
American Society of Anesthesiologists. Practice advisory for the perioperative management of patients with cardiac implantable electronic devices: pacemakers and implantable cardioverter-defibrillators: an updated report by the american society of anesthesiologists task force on perioperative management of patients with cardiac implantable electronic devices. Anesthesiology. 2011 Feb;114(2):247-61. doi: 10.1097/ALN.0b013e3181fbe7f6. No abstract available.
PubMed 21245737Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
PubMed 21722856Stone KR, McPherson CA. Assessment and management of patients with pacemakers and implantable cardioverter defibrillators. Crit Care Med. 2004 Apr;32(4 Suppl):S155-65. doi: 10.1097/01.ccm.0000115622.73988.6e.
PubMed 15064674Rozner MA. The patient with a cardiac pacemaker or implanted defibrillator and management during anaesthesia. Curr Opin Anaesthesiol. 2007 Jun;20(3):261-8. doi: 10.1097/ACO.0b013e32814f1c4a.
PubMed 17479032Korantzopoulos P, Letsas KP, Grekas G, Goudevenos JA. Pacemaker dependency after implantation of electrophysiological devices. Europace. 2009 Sep;11(9):1151-5. doi: 10.1093/europace/eup195. Epub 2009 Jul 16.
PubMed 19617204Cheng A, Nazarian S, Spragg DD, Bilchick K, Tandri H, Mark L, Halperin H, Calkins H, Berger RD, Henrikson CA. Effects of surgical and endoscopic electrocautery on modern-day permanent pacemaker and implantable cardioverter-defibrillator systems. Pacing Clin Electrophysiol. 2008 Mar;31(3):344-50. doi: 10.1111/j.1540-8159.2008.00996.x.
PubMed 18307631Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x.
PubMed 15009852Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202.
PubMed 9411221Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
PubMed 11907286
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol
- ClinicalTrials.gov ID
- NCT01572246
- Acronym / sponsor ID
- ISROTH20028
- Conditions
- Heart Failure, Tachycardia, Ventricular
- Keywords
- electrosurgery, Cardiac surgical procedures, Surgical procedures, operative, Defibrillators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- May 2012
- Primary completion
- 14 Sep 2016 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-cardiac above-the-waist surgery | – | Other: Optimal placement of return padSubjects with an implanted ICD who present for a non-cardiac above-the-waist surgical procedure involving monopolar electrocautery |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with ICDs (including cardiac resynchronization therapy system-defibrillators) scheduled for surgery involving ME.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal placement of return padThe ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators. | Other | Non-cardiac above-the-waist surgery |
Primary outcome
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.
1 secondary outcome
Incidence of unexpected preoperative ICD-related problems
Time frame: Up to 6 months prior to date of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Background: PubMed 21245737American Society of Anesthesiologists. Practice advisory for the perioperative management of patients with cardiac implantable electronic devices: pacemakers and implantable cardioverter-defibrillators: an updated report by the american society of anesthesiologists task force on perioperative management of patients with cardiac implantable electronic devices. Anesthesiology. 2011 Feb;114(2):247-61. doi: 10.1097/ALN.0b013e3181fbe7f6. No abstract available.
- Background: PubMed 21722856Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
- Background: PubMed 15064674Stone KR, McPherson CA. Assessment and management of patients with pacemakers and implantable cardioverter defibrillators. Crit Care Med. 2004 Apr;32(4 Suppl):S155-65. doi: 10.1097/01.ccm.0000115622.73988.6e.
- Background: PubMed 17479032Rozner MA. The patient with a cardiac pacemaker or implanted defibrillator and management during anaesthesia. Curr Opin Anaesthesiol. 2007 Jun;20(3):261-8. doi: 10.1097/ACO.0b013e32814f1c4a.
- Background: PubMed 19617204Korantzopoulos P, Letsas KP, Grekas G, Goudevenos JA. Pacemaker dependency after implantation of electrophysiological devices. Europace. 2009 Sep;11(9):1151-5. doi: 10.1093/europace/eup195. Epub 2009 Jul 16.
- Background: PubMed 18307631Cheng A, Nazarian S, Spragg DD, Bilchick K, Tandri H, Mark L, Halperin H, Calkins H, Berger RD, Henrikson CA. Effects of surgical and endoscopic electrocautery on modern-day permanent pacemaker and implantable cardioverter-defibrillator systems. Pacing Clin Electrophysiol. 2008 Mar;31(3):344-50. doi: 10.1111/j.1540-8159.2008.00996.x.
- Background: PubMed 15009852Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. doi: 10.1111/j.1540-8159.2004.00430.x.
- Background: PubMed 9411221Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202.
- Background: PubMed 11907286Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Schulman, MD principal investigator
Oregon Health and Science University
Charles Henrikson, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Tachycardia, Ventricular, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of electromagnetic interference (EMI) (time frame: During surgery on day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572246, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.