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|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P160015 S001/ PAS001 |
| Date Original Protocol Accepted |
06/05/2020
|
| Date Current Protocol Accepted |
07/16/2026
|
| Study Name |
AED 3 and Pad Placement PAS
|
| Device Name |
AED 3 defibrillator
|
| General Study Protocol Parameters |
| Study Design |
Other Study Design
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, observational study.
Enrollment in this study is expected to take approximately 36 months. The full study timeline is below. Subjects are enrolled once EMS personnel are on-scene and able to make an assessment of outcome measures listed below. No data will be collected about CPR quality or patient outcomes. Subjects will not be followed after the assessment of study objectives.
The objectives of the study are:
• Demonstrate appropriate CPR sensor placement on pediatric and adult patients
• Demonstrate delivery of appropriate energy level shocks to pediatric and adult patients
Additionally, a limited human factors study will be conducted using manikins. Participants will be randomly assigned to either the ‘adult scenario’ or the ‘pediatric scenario’.
|
| Study Population |
Candidates for this study must meet all of the following Inclusion criteria:
1. Suspected out-of-hospital cardiac arrest
2. Use of ZOLL AED 3 PAD (running software v. 1.03.602 or newer (US) or v. 6.03.006 or newer (International)) with Uni-padz III
3. Unconsciousness
4. Absence of breathing
5. Absence of pulse and other signs of circulation
The limited human factors study will be conducted using adult and pediatric manikins.
|
| Sample Size |
Approximately 73 adult subjects and 15 pediatric subjects were planned to be enrolled in this study. Only 38 adult subjects have been enrolled so far.
There are currently two sites:
1. The University at Buffalo (UB), initiated on March 30, 2021.
2. Colonie EMS (New York) initiated on December 19th, 2022.
The human factors study will be conducted in 32 lay rescuers and 32 professional users.
|
| Key Study Endpoints |
Study endpoints include appropriate placement of the electrodes which will be assessed by EMS personnel based on observations made when they arrive on scene, the appropriate selection of adult or pediatric mode which will be assessed by identifying that the child button was pressed when the estimated age is less than 8 years old, and the delivery of defibrillation energy which will be determined by documented whether the energy was age-appropriate if a shock was delivered.
Endpoints assessed for the human factors study are:
- The appropriate placement of the CPR sensor
- The appropriate selection of adult or pediatric mode
|
| Follow-up Visits and Length of Follow-up |
Subjects will not be followed after the assessment of study objectives
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Pads placed appropriately based on age: Yes (38), No (0)
Patient mode appropriately selected: Yes (37), No (0), Unkown (1)
Note: Pads were placed on participant 477011-004 but EMS arrived and removed AED before the device completed the startup process. This is the unknown subject.
Effectiveness Results
Appropriate shock energy delivered: Yes (8), No (0), No Shocks (29), Unkown (1)
Note: Unknown is for the same reason as above.
|
| Actual Number of Patients Enrolled |
38
|
| Actual Number of Sites Enrolled |
Two study sties enrolled:
1) University of Buffalo (Buffalo, NY)
2) Colonie EMS (New York, NY)
|
| Patient Follow-up Rate |
N/A
|
