Ideal Pacer Pad Position Study

NCT03898050 | Completed DMC

• 1 other identifier: HP-00085450
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Bradycardia

Keywords

transcutaneous pacer pad; transcutaneous cardiac pacing

Outcome Measures

Primary Outcomes (1)

• cardiac capture mA

  minimal current of energy required to achieve cardiac capture

  one minute

Study Arms (2)

A-P

EXPERIMENTAL

Anterior - Posterior pad placement

Procedure: transcutaneous cardiac pacing

A-L

EXPERIMENTAL

Anterior - Lateral pad placement

Procedure: transcutaneous cardiac pacing

Interventions

transcutaneous cardiac pacing PROCEDURE

transcutaneous cardiac pacing

A-L; A-P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>17 years.
• Scheduled for cardioversion of supraventricular dysrhythmia in the electrophysiology lab.
• Full decision-making capacity.
• Fluent in English language.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

• Moayedi S, Patel P, Brady N, Witting M, Dickfeld TL. Anteroposterior pacer pad position is better than anterolateral for transcutaneous cardiac pacing. Resuscitation. 2022 Dec;181:140-146. doi: 10.1016/j.resuscitation.2022.11.009. Epub 2022 Nov 18.

  PMID: 36410605 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: September 30, 2019
• Primary Completion: February 18, 2022
• Study Completion: June 30, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)