Ideal Pacer Pad Position Study

Not Applicable

Completed

• Conditions: Symptomatic Bradycardia
• Interventions: Procedure: transcutaneous cardiac pacing

• Registration Number: NCT03898050
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-01
• Study Start: 2019-09-30
• Primary Completion: 2022-02-18
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A-P	transcutaneous cardiac pacing	Anterior - Posterior pad placement
A-L	transcutaneous cardiac pacing	Anterior - Lateral pad placement

Primary Outcome Measures

Name	Time	Method
cardiac capture mA	one minute	minimal current of energy required to achieve cardiac capture

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States