Clinical trial NCT03898050: Ideal Pacer Pad Position Study
Official title: The Ideal Transcutaneous Cardiac Pacer Pad Position Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Bradycardia
Keywords: transcutaneous pacer pad
transcutaneous cardiac pacing
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: cardiac capture mA
timeFrame: one minute
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References: