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Ideal Pacer Pad Position Study

Primary Purpose

Symptomatic Bradycardia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcutaneous cardiac pacing
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Bradycardia focused on measuring transcutaneous pacer pad, transcutaneous cardiac pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A-P

A-L

Arm Description

Anterior - Posterior pad placement

Anterior - Lateral pad placement

Outcomes

Primary Outcome Measures

cardiac capture mA
minimal current of energy required to achieve cardiac capture

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
October 3, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03898050
Brief Title
Ideal Pacer Pad Position Study
Official Title
The Ideal Transcutaneous Cardiac Pacer Pad Position Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Bradycardia
Keywords
transcutaneous pacer pad, transcutaneous cardiac pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study will employ a prospective crossover design in which participants will function as their own controls. It will compare the pacing threshold of the two most common pacer pad placement positions. Pad placement order will be randomized to eliminate carry-over effect.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-P
Arm Type
Experimental
Arm Description
Anterior - Posterior pad placement
Arm Title
A-L
Arm Type
Experimental
Arm Description
Anterior - Lateral pad placement
Intervention Type
Procedure
Intervention Name(s)
transcutaneous cardiac pacing
Intervention Description
transcutaneous cardiac pacing
Primary Outcome Measure Information:
Title
cardiac capture mA
Description
minimal current of energy required to achieve cardiac capture
Time Frame
one minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ideal Pacer Pad Position Study

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