- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898050
Ideal Pacer Pad Position Study
October 3, 2022 updated by: Siamak Moayedi, MD, University of Maryland, Baltimore
The Ideal Transcutaneous Cardiac Pacer Pad Position Study
Temporary transcutaneous cardiac pacing is a life-saving procedure in patients with unstable bradycardia.
The American Heart Association (AHA) guidelines for the management of unstable bradycardia recommend initiating transcutaneous pacing in patients unresponsive to atropine while addressing the primary cause of the bradycardia.
The two most commonly described pacer pad application sites are the anterior-posterior (A-P) position (positive pad placed under the left scapula and negative pad placed on the left anterior lower chest wall) and the anterior-lateral (A-L) position (positive pad placed on the right anterior chest wall and negative pad placed on the left lower axilla).
Major resuscitation organization (AHA, European, Australian) guidelines and text books of emergency medicine recommendations for pacer pad placement do not address the issue of which set of positions are preferred.
There are no published human studies addressing ideal pacer pad placement.
This study's objective is to assess if there is a significant difference in the pacing threshold (mA) between these two pacer pad positions.
The study hypothesis is that the anterior-posterior position will require a lower current and cause less involuntary muscle contraction.
The investigators plan to enroll volunteer human subjects undergoing elective cardioversion in the electrophysiology laboratory for atrial fibrillation/flutter.
After successful cardioversion to a sinus rhythm, each subject will be transcutaneously paced to mechanical capture in both pacer pad positions.
Optimal placement will be determined by the pad position with the lowest current required for capture.
The conclusions of this study will provide evidence for the optimal choice regarding pacer pad placement, which can be used in future resuscitation guidelines.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Temporary transcutaneous cardiac pacing is a life-saving procedure in patients with unstable bradycardia.
The American Heart Association (AHA) guidelines for the management of unstable bradycardia recommend initiating transcutaneous pacing in patients unresponsive to atropine while addressing the primary cause of the bradycardia.
The two most commonly described pacer pad application sites are the anterior-posterior (A-P) position (positive pad placed under the left scapula and negative pad placed on the left anterior lower chest wall) and the anterior-lateral (A-L) position (positive pad placed on the right anterior chest wall and negative pad placed on the left lower axilla).
Major resuscitation organization (AHA, European, Australian) guidelines and text books of emergency medicine recommendations for pacer pad placement do not address the issue of which set of positions are preferred.
There are no published human studies addressing ideal pacer pad placement.
This study's objective is to assess if there is a significant difference in the pacing threshold (mA) between these two pacer pad positions.
The study hypothesis is that the anterior-posterior position will require a lower current and cause less involuntary muscle contraction.
The investigators plan to enroll volunteer human subjects undergoing elective cardioversion in the electrophysiology laboratory for atrial fibrillation/flutter.
After successful cardioversion to a sinus rhythm, each subject will be transcutaneously paced to mechanical capture in both pacer pad positions.
Optimal placement will be determined by the pad position with the lowest current required for capture.
The conclusions of this study will provide evidence for the optimal choice regarding pacer pad placement, which can be used in future resuscitation guidelines.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21202
- University of Maryland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age >17 years.
- Scheduled for cardioversion of supraventricular dysrhythmia in the electrophysiology lab.
- Full decision-making capacity.
- Fluent in English language.
Exclusion Criteria:
- Age <18 years.
- Unable to provide informed consent for any reason (including altered mental status or hemodynamic instability).
- Prisoner, under custody or ward of state.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A-P
Anterior - Posterior pad placement
|
transcutaneous cardiac pacing
|
Experimental: A-L
Anterior - Lateral pad placement
|
transcutaneous cardiac pacing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiac capture mA
Time Frame: one minute
|
minimal current of energy required to achieve cardiac capture
|
one minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2019
Primary Completion (Actual)
February 18, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
March 29, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
October 5, 2022
Last Update Submitted That Met QC Criteria
October 3, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00085450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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