AED 3 Post-Approval Study

Not Applicable

Completed

• Conditions: Cardiac Arrest, Out-Of-Hospital
• Interventions: Device: AED 3 with Uni-padz

• Registration Number: NCT05013333
• Lead Sponsor: Zoll Medical Corporation

Brief Summary

Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-30
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-19
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Suspected out-of-hospital cardiac arrest
• Use of ZOLL AED 3 public-access defibrillator (running software v.1.03.602 or newer (US) or v. 6.03.006 or newer(OUS)) with Uni-padz III
• Unconsciousness
• Absence of breathing
• Absence of pulse and other signs of circulation

Exclusion Criteria

• Pre-existing Do Not Attempt Resuscitation (DNAR) orders
• No evidence of cardiac arrest

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AED 3 with Uni-padz	AED 3 with Uni-padz	-

Primary Outcome Measures

Name	Time	Method
Selection of adult or pediatric mode	Procedure (At time of device placement)	Rate of appropriate selection of child mode by pressing "Child Mode" button or adult mode by not pressing "Child Mode" button determined by energy level of first shock
CPR sensor placement	Procedure (At time of device placement)	Rate of appropriate placement of the CPR electrodes and compression sensor

Trial Locations

Locations (2)

University at Buffalo; 🇺🇸 Buffalo, New York, United States

Colonie EMS; 🇺🇸 Latham, New York, United States