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AED 3 Post-Approval Study

Primary Purpose

Cardiac Arrest, Out-Of-Hospital

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AED 3 with Uni-padz
Sponsored by
Zoll Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest, Out-Of-Hospital

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University at Buffalo
  • Colonie EMS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AED 3 with Uni-padz

Arm Description

Outcomes

Primary Outcome Measures

CPR sensor placement
Rate of appropriate placement of the CPR electrodes and compression sensor
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

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
April 6, 2023
Sponsor
Zoll Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05013333
Brief Title
AED 3 Post-Approval Study
Official Title
Post-Approval Study for AED 3 With Uni-padz
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AED 3 with Uni-padz
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
AED 3 with Uni-padz
Intervention Description
Use of AED 3 with Uni-padz by lay rescuer
Primary Outcome Measure Information:
Title
CPR sensor placement
Description
Rate of appropriate placement of the CPR electrodes and compression sensor
Time Frame
Procedure (At time of device placement)
Title
Selection of adult or pediatric mode
Description
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
Time Frame
Procedure (At time of device placement)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Colonie EMS
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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AED 3 Post-Approval Study

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