NCT05013333

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
34mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2021Feb 2029

Study Start

First participant enrolled

March 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

7.9 years

First QC Date

August 16, 2021

Last Update Submit

August 12, 2025

Conditions

Cardiac Arrest, Out-Of-Hospital

Outcome Measures

Primary Outcomes (2)

  • CPR sensor placement

    Rate of appropriate placement of the CPR electrodes and compression sensor

    Procedure (At time of device placement)

  • 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)

Study Arms (1)

AED 3 with Uni-padz

OTHER
Device: AED 3 with Uni-padz

Interventions

AED 3 with Uni-padzDEVICE

Use of AED 3 with Uni-padz by lay rescuer

AED 3 with Uni-padz

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University at Buffalo

Buffalo, New York, 14203, United States

Location

Colonie EMS

Latham, New York, 12110, United States

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 19, 2021

Study Start

March 30, 2021

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)