Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03898050
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2019-03-29
Brief Title:
Ideal Pacer Pad Position Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Ideal Transcutaneous Cardiac Pacer Pad Position Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studys 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 fibrillationflutter 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 studys 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 fibrillationflutter 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None