AED 3 Post-Approval Study

ZOLL Medical

Status: Active, not recruiting

Conditions: Cardiac Arrest, Out-Of-Hospital

Treatments: Device: AED 3 with Uni-padz

Study type: Interventional

Funder types: Industry

Identifiers

NCT05013333

47701

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

AED 3 with Uni-padz

Other group

Treatment:

Device: AED 3 with Uni-padz