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Pacer Pad Position Study

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ClinicalTrials.gov Identifier: NCT03898050
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Siamak Moayedi, MD, University of Maryland, College Park

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
Symptomatic Bradycardia Procedure: transcutaneous cardiac pacing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Ideal Transcutaneous Cardiac Pacer Pad Position Study
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. cardiac capture mA [ Time Frame: one minute ]
    minimal current of energy required to achieve cardiac capture



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898050


Contacts
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Contact: Siamak Moayedi, MD 4103288025 mak.moayedi@som.umaryland.edu
Contact: Michael Witting, MD 4103288025 mwitting@som.umaryland.edu

Sponsors and Collaborators
University of Maryland, College Park

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Responsible Party: Siamak Moayedi, MD, Assistant Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03898050     History of Changes
Other Study ID Numbers: HP-00085450
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Siamak Moayedi, MD, University of Maryland, College Park:
transcutaneous pacer pad
transcutaneous cardiac pacing

Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes