Pacemaker, ArtificialNCT00586248
A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for Regional Anesthesia
An observational study of Pacemaker, Artificial, run by Mayo Clinic at 1 site in United States.
Trial summary
In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pacemaker, Artificial
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3rd degree av block atrial fibrilation chf
Who may be able to join
- age greater than 18, ASA II or III status
Who cannot join
- Pregnancy, unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
About this study
Official title: A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for
In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function.
Read the detailed description
The principle of the nerve stimulation technique consists of using a battery powered peripheral nerve stimulator to generate electrical stimuli through an insulated needle at appropriate anatomical locations. The electrical impulses then trigger depolarization as insulated needle approaches the target nerve bundles. Braun Stimuplex, a common nerve stimulator used for peripheral nerve localization, is currently being used in the United States and other countries. Previous studies have suggested it to be a reliable stimulator for the purpose of peripheral nerve blocks. The operational manual however indicated that this device should not be used in patients with cardiac pacemaker because malfunction of the pacemaker may occur. Literature search on the topic of pacemaker interference from peripheral nerve stimulator showed that there was one case of pacemaker interference caused by activation of a nerve stimulator, resulting in cardiac arrest in a patient with a fixed-rate ventricular pacemaker. Studies and case reports suggest that unipolar electrode seems to be most susceptible to interferences from electrosurgical equipment, TENS unit, spinal cord stimulators. Perhaps this is the reason why the manufacturer of the peripheral nerve stimulator recommends against the use of peripheral nerve stimulator in patients with pacemakers. With the advancements of modern pacemakers technology, it is our experience; interscalene nerve blocks and other peripheral nerve blocks using the nerve stimulator can be performed in patients with pacemakers without notable interferences with pacemaker functions and perhaps the initial recommendation by the peripheral nerve stimulator manufacturer can be modified. In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation (most likely scenario to interfere with pacemaker function) by varying the configurations of the pacemaker leads (unipolar vs. bipolar pacer lead configuration) and by varying the positions of the positive electrode of the stimulator.
- Conditions
- Pacemaker, Artificial
- Keywords
- Peripheral nerve stimulator, cardiac pacemaker
What is being measured
The primary outcome is the main question the study is designed to answer.
Over sensing of pacemaker during nerve stimulation
Measured: during nerve stimulation
Secondary outcomes (1)
Pacemaker mode change during nerve stimulation
Measured: during nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pacemaker, ArtificialStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Ruei Hsin D Wang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586248
- Sponsor's protocol ID
- 06-002237
- Status last verified
- May 2007
- First submitted
- 21 Dec 2007
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.
PubMed 15195936De Andres J, Alonso-Inigo JM, Sala-Blanch X, Reina MA. Nerve stimulation in regional anesthesia: theory and practice. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):153-74. doi: 10.1016/j.bpa.2004.11.002.
PubMed 15966491Rasmussen MJ, Hayes DL, Vlietstra RE, Thorsteinsson G. Can transcutaneous electrical nerve stimulation be safely used in patients with permanent cardiac pacemakers? Mayo Clin Proc. 1988 May;63(5):443-5. doi: 10.1016/s0025-6196(12)65639-0.
PubMed 3258950O'Flaherty D, Wardill M, Adams AP. Inadvertent suppression of a fixed rate ventricular pacemaker using a peripheral nerve stimulator. Anaesthesia. 1993 Aug;48(8):687-9. doi: 10.1111/j.1365-2044.1993.tb07181.x.
PubMed 8214459Kaiser H, Niesel HC, Hans V. [Fundamentals and requirements of peripheral electric nerve stimulation. A contribution to the improvement of safety standards in regional anesthesia]. Reg Anaesth. 1990 Sep;13(7):143-7. German.
PubMed 2236709
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for
- ClinicalTrials.gov ID
- NCT00586248
- Acronym / sponsor ID
- 06-002237
- Conditions
- Pacemaker, Artificial
- Keywords
- Peripheral nerve stimulator, cardiac pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 Jan 2008 (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.
In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function.
Detailed description
The principle of the nerve stimulation technique consists of using a battery powered peripheral nerve stimulator to generate electrical stimuli through an insulated needle at appropriate anatomical locations. The electrical impulses then trigger depolarization as insulated needle approaches the target nerve bundles. Braun Stimuplex, a common nerve stimulator used for peripheral nerve localization, is currently being used in the United States and other countries. Previous studies have suggested it to be a reliable stimulator for the purpose of peripheral nerve blocks. The operational manual however indicated that this device should not be used in patients with cardiac pacemaker because malfunction of the pacemaker may occur. Literature search on the topic of pacemaker interference from peripheral nerve stimulator showed that there was one case of pacemaker interference caused by activation of a nerve stimulator, resulting in cardiac arrest in a patient with a fixed-rate ventricular pacemaker. Studies and case reports suggest that unipolar electrode seems to be most susceptible to interferences from electrosurgical equipment, TENS unit, spinal cord stimulators. Perhaps this is the reason why the manufacturer of the peripheral nerve stimulator recommends against the use of peripheral nerve stimulator in patients with pacemakers. With the advancements of modern pacemakers technology, it is our experience; interscalene nerve blocks and other peripheral nerve blocks using the nerve stimulator can be performed in patients with pacemakers without notable interferences with pacemaker functions and perhaps the initial recommendation by the peripheral nerve stimulator manufacturer can be modified. In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation (most likely scenario to interfere with pacemaker function) by varying the configurations of the pacemaker leads (unipolar vs. bipolar pacer lead configuration) and by varying the positions of the positive electrode of the stimulator.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3rd degree av block atrial fibrilation chf
Key inclusion criteria (1 listed)
- age greater than 18, ASA II or III status
Key exclusion criteria (1 listed)
- Pregnancy, unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Over sensing of pacemaker during nerve stimulation
Time frame: during nerve stimulation
1 secondary outcome
Pacemaker mode change during nerve stimulation
Time frame: during nerve stimulation
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 4 Jan 2008.
- Background: PubMed 15195936Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.
- Background: PubMed 15966491De Andres J, Alonso-Inigo JM, Sala-Blanch X, Reina MA. Nerve stimulation in regional anesthesia: theory and practice. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):153-74. doi: 10.1016/j.bpa.2004.11.002.
- Background: PubMed 3258950Rasmussen MJ, Hayes DL, Vlietstra RE, Thorsteinsson G. Can transcutaneous electrical nerve stimulation be safely used in patients with permanent cardiac pacemakers? Mayo Clin Proc. 1988 May;63(5):443-5. doi: 10.1016/s0025-6196(12)65639-0.
- Background: PubMed 8214459O'Flaherty D, Wardill M, Adams AP. Inadvertent suppression of a fixed rate ventricular pacemaker using a peripheral nerve stimulator. Anaesthesia. 1993 Aug;48(8):687-9. doi: 10.1111/j.1365-2044.1993.tb07181.x.
- Background: PubMed 2236709Kaiser H, Niesel HC, Hans V. [Fundamentals and requirements of peripheral electric nerve stimulation. A contribution to the improvement of safety standards in regional anesthesia]. Reg Anaesth. 1990 Sep;13(7):143-7. German.
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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.
Ruei Hsin D Wang, MD principal investigator
Mayo Clinic
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 Pacemaker, Artificial, run by Mayo Clinic 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 1 inclusion and 1 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 4 Jan 2008. 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?
Over sensing of pacemaker during nerve stimulation (time frame: during nerve stimulation). 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 NCT00586248, which also lists 5 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 4 Jan 2008.