Electromagnetic InterferenceNCT02617355
Interference Between Surgical Magnetic Drapes and Pacemakers
A study testing Prototype surgical magnetic drape, Green Covidien Magnetic Drape and Jac-Cell Medic Reusable Magnetic Pad in people with Electromagnetic Interference, run by Maisonneuve-Rosemont Hospital.
Trial summary
This study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electromagnetic Interference
- What is being tested?
- Prototype surgical magnetic drape, Green Covidien Magnetic Drape and Jac-Cell Medic Reusable Magnetic Pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Nov 2011
- Phase
- Interventional
- 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
Who may be able to join
- Patients with a pacemaker
- 18 years or older
Who cannot join
- Patients with implantable cardioverter-defibrillator (ICD)
- Patients in whom the magnet rate cardiac rhythm is indistinguishable from their baseline rhythm
- Refusal/Inability to consent
- Language other than French or English
About this study
Official title: Interference Between Surgical Magnetic Drapes and Pacemakers: An Observational Study Comparing Commercially Available Devices and a New Magnetically Isolated Drape
This study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.
Read the detailed description
Magnetic fields may potentially interfere with the function of cardiovascular implantable electronic devices. Sterile magnetic drapes used to hold surgical instruments are often placed on the patient's thorax, and they are likely to interfere with the function of these devices.
This study compares the magnetic interference of a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to the Covidien magnetic drape and 3 other commercially available surgical magnetic drapes.
- Conditions
- Electromagnetic Interference
- Being tested
- Prototype surgical magnetic drape, Green Covidien Magnetic Drape, Jac-Cell Medic Reusable Magnetic Pad, DeRoyal Magnetic Pad size 20" x 16", DeRoyal Magnetic Pad size 10" x 16"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype surgical magnetic drapeDevice
New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax
Green Covidien Magnetic DrapeDevice
Green Covidien Magnetic Drape applied to the patient's thorax
Jac-Cell Medic Reusable Magnetic PadDevice
Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax
DeRoyal Magnetic Pad size 20" x 16"Device
Magnetic Instrument Pad #25-002, size 20" x 16", DeRoyal Industries Inc applied to the patient's thorax
DeRoyal Magnetic Pad size 10" x 16"Device
Magnetic Instrument Pad #25-001, size 10" x 16", DeRoyal Industries Inc applied to the patient's thorax
| Study group | Role | What they receive |
|---|---|---|
| Prototype vs Covidien magnetic drape | Other | New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs Covidien magnetic drape Receives: Device: Prototype surgical magnetic drape; Device: Green Covidien Magnetic Drape |
| Prototype vs 4 commercial drapes | Other | New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs 4 commercially available magnetic drapes:
Green Covidien Magnetic Drape Jac-Cell Medic Reusable Magnetic Pad DeRoyal Magnetic Pad size 10" x 16" DeRoyal Magnetic Pad size 20" x 16" Receives: Device: Prototype surgical magnetic drape; Device: Green Covidien Magnetic Drape; Device: Jac-Cell Medic Reusable Magnetic Pad; Device: DeRoyal Magnetic Pad size 20" x 16"; Device: DeRoyal Magnetic Pad size 10" x 16" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of magnetic interference
Percentage of patients experiencing magnetic interference with the application of each surgical magnetic drape.
Magnetic interference defined as a cardiac rhythm change to asynchronous and identical to that produced by a round magnet rhythm over the pacemaker.
Measured: Within 2 minutes after placement of surgical magnetic drape to the patient's chest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electromagnetic InterferenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Zaphiratos, Maisonneuve-Rosemont Hospital
- Investigators
- Valerie Zaphiratos, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617355
- Sponsor's protocol ID
- 11061
- Status last verified
- Nov 2015
- First submitted
- 24 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interference Between Surgical Magnetic Drapes and Pacemakers: An Observational Study Comparing Commercially Available Devices and a New Magnetically Isolated Drape
- ClinicalTrials.gov ID
- NCT02617355
- Acronym / sponsor ID
- 11061
- Conditions
- Electromagnetic Interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Nov 2015 (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 study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.
Detailed description
Magnetic fields may potentially interfere with the function of cardiovascular implantable electronic devices. Sterile magnetic drapes used to hold surgical instruments are often placed on the patient's thorax, and they are likely to interfere with the function of these devices.
This study compares the magnetic interference of a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to the Covidien magnetic drape and 3 other commercially available surgical magnetic drapes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prototype vs Covidien magnetic drape | Other | Device: Prototype surgical magnetic drape, Device: Green Covidien Magnetic DrapeNew prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs Covidien magnetic drape |
| Prototype vs 4 commercial drapes | Other | Device: Prototype surgical magnetic drape, Device: Green Covidien Magnetic Drape, Device: Jac-Cell Medic Reusable Magnetic Pad, Device: DeRoyal Magnetic Pad size 20" x 16", Device: DeRoyal Magnetic Pad size 10" x 16"New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs 4 commercially available magnetic drapes: Green Covidien Magnetic Drape Jac-Cell Medic Reusable Magnetic Pad DeRoyal Magnetic Pad size 10" x 16" DeRoyal Magnetic Pad size 20" x 16" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a pacemaker
- 18 years or older
Key exclusion criteria (4 listed)
- Patients with implantable cardioverter-defibrillator (ICD)
- Patients in whom the magnet rate cardiac rhythm is indistinguishable from their baseline rhythm
- Refusal/Inability to consent
- Language other than French or English
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 |
|---|---|---|
| Prototype surgical magnetic drapeNew prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax | Device | Prototype vs 4 commercial drapes, Prototype vs Covidien magnetic drape |
| Green Covidien Magnetic DrapeGreen Covidien Magnetic Drape applied to the patient's thorax | Device | Prototype vs 4 commercial drapes, Prototype vs Covidien magnetic drape |
| Jac-Cell Medic Reusable Magnetic PadJaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax | Device | Prototype vs 4 commercial drapes |
| DeRoyal Magnetic Pad size 20" x 16"Magnetic Instrument Pad #25-002, size 20" x 16", DeRoyal Industries Inc applied to the patient's thorax | Device | Prototype vs 4 commercial drapes |
| DeRoyal Magnetic Pad size 10" x 16"Magnetic Instrument Pad #25-001, size 10" x 16", DeRoyal Industries Inc applied to the patient's thorax | Device | Prototype vs 4 commercial drapes |
Primary outcome
Percentage of magnetic interference
Time frame: Within 2 minutes after placement of surgical magnetic drape to the patient's chest
Percentage of patients experiencing magnetic interference with the application of each surgical magnetic drape. Magnetic interference defined as a cardiac rhythm change to asynchronous and identical to that produced by a round magnet rhythm over the pacemaker.
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 30 Nov 2015.
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.
Valerie Zaphiratos, MD principal investigator
Maisonneuve-Rosemont Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Prototype surgical magnetic drape, Green Covidien Magnetic Drape and Jac-Cell Medic Reusable Magnetic Pad in people with Electromagnetic Interference, run by Maisonneuve-Rosemont Hospital.
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 2 inclusion and 4 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Percentage of magnetic interference (time frame: Within 2 minutes after placement of surgical magnetic drape to the patient's chest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2015.