Ideal Pacer Pad Position Study

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03898050
Collaborator
(none)
20
1
2
33
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: transcutaneous cardiac pacing
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Ideal Transcutaneous Cardiac Pacer Pad Position Study
Actual Study Start Date :
Sep 30, 2019
Actual Primary Completion Date :
Feb 18, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: A-P

Anterior - Posterior pad placement

Procedure: transcutaneous cardiac pacing
transcutaneous cardiac pacing

Experimental: A-L

Anterior - Lateral pad placement

Procedure: transcutaneous cardiac pacing
transcutaneous cardiac pacing

Outcome Measures

Primary Outcome Measures

  1. cardiac capture mA [one minute]

    minimal current of energy required to achieve cardiac capture

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Medical Center Baltimore Maryland United States 21202

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Siamak Moayedi, MD, Assistant Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT03898050
Other Study ID Numbers:
  • HP-00085450
First Posted:
Apr 1, 2019
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Siamak Moayedi, MD, Assistant Professor, University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022