Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03898050 |
| Other study ID # |
HP-00085450 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2019 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
October 2022 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
