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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05013333
Other study ID # 47701
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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