Cardiac Arrest, Out-Of-Hospital Clinical Trial
Official title:
Post-Approval Study for AED 3 With Uni-padz
Verified date | April 2023 |
Source | Zoll Medical Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University at Buffalo | Buffalo | New York |
United States | Colonie EMS | Latham | New York |
Lead Sponsor | Collaborator |
---|---|
Zoll Medical Corporation |
United States,
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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