AED 3 Post-Approval Study

Cardiac Arrest, Out-Of-Hospital Clinical Trial

Official title:

Post-Approval Study for AED 3 With Uni-padz

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05013333
• Other study ID #: 47701
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 88
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest, Out-Of-Hospital
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• AED 3 with Uni-padz
Use of AED 3 with Uni-padz by lay rescuer

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	Colonie EMS	Latham	New York

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPR sensor placement	Rate of appropriate placement of the CPR electrodes and compression sensor	Procedure (At time of device placement)
Primary	Selection of adult or pediatric mode	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	Procedure (At time of device placement)