AED 3 for Cardiac Arrest

Not currently recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Zoll Medical Corporation

Disqualifiers: Pre-existing DNAR orders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the AED 3 with Uni-padz for emergencies when someone's heart stops beating (cardiac arrest). Researchers aim to ensure the device functions effectively for both children and adults. The trial evaluates whether sensors are placed correctly and if the shock delivered by the device is appropriate for different ages. It seeks participants who have experienced a sudden out-of-hospital cardiac arrest, are unconscious, not breathing, and have no pulse. As an unphased trial, this study offers participants the opportunity to contribute to potentially life-saving advancements in emergency medical technology.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for use in cardiac arrest patients?

Research shows that using an Automated External Defibrillator (AED) like the ZOLL AED 3 can significantly improve survival rates in cardiac arrest cases. Immediate defibrillation increases survival chances to 50%-74%, indicating the AED 3's effectiveness in emergencies and suggesting ease of use.

The device includes a feature called Real CPR Help, which provides feedback on CPR quality. This assists users in performing CPR correctly, ensuring safe and effective care during critical moments. Although specific safety data from human trials for the AED 3 with Uni-padz is not detailed, its current use in emergencies supports its safety. Its use in such situations demonstrates general safety for people during cardiac events. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AED 3 with Uni-padz because it could transform how we respond to cardiac arrest. Unlike traditional defibrillators, AED 3 is designed to be more user-friendly with advanced guidance features, making it easier for people without medical training to use effectively. Additionally, the Uni-padz are versatile, suitable for both adult and pediatric patients, potentially reducing the time it takes to switch devices in emergencies. This innovative approach aims to improve survival rates by ensuring faster and more accurate defibrillation during critical moments.

What evidence suggests that the AED 3 with Uni-padz is effective for cardiac arrest?

Research has shown that using an Automated External Defibrillator (AED) can greatly improve survival rates during sudden cardiac arrest. Studies indicate that having an AED nearby can increase survival chances to 50%-74% if used immediately. In this trial, participants will use the AED 3 with Uni-padz, designed to deliver life-saving shocks quickly, minimizing delay, which is crucial for effective CPR (cardiopulmonary resuscitation). Better pad placement, as with the AED 3, is linked to a higher chance of restoring a normal heartbeat. Overall, AEDs like the AED 3 can significantly improve survival outcomes in emergencies. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who are unconscious, not breathing, and show no signs of circulation, suggesting an out-of-hospital cardiac arrest. They must be treated with a ZOLL AED 3 defibrillator using the latest software and Uni-padz III. People with Do Not Attempt Resuscitation (DNAR) orders or without evidence of cardiac arrest cannot participate.

Inclusion Criteria

You are not conscious.

You are not breathing.

Criterion: You have used a specific type of defibrillator called ZOLL AED 3 with certain software versions and pads.

Exclusion Criteria

You have a "Do Not Attempt Resuscitation" (DNAR) order in place.

You have not experienced a heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Demonstrate appropriate CPR sensor placement and delivery of appropriate energy level of shocks to pediatric and adult patients

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AED 3 with Uni-padz

Trial Overview The study tests how well CPR sensors can be placed on both children and adults during emergencies, and if the right amount of shock energy is delivered to patients using the ZOLL AED 3 defibrillator equipped with Uni-padz.

How Is the Trial Designed?

Group I: AED 3 with Uni-padz Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zoll Medical Corporation

Lead Sponsor

Trials

48

Recruited

23,100+

Citations

1. zoll.com zoll.com/en-us/products/emergency-care/aeds/zoll-aed-3

ZOLL AED 3 Defibrillator Minimizing pause time allows for more lifesaving CPR, improves CPR quality, and can improve patient outcomes from sudden cardiac arrest. Integrated pediatric ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10676231/

The Role of Automated External Defibrillator Use in the Out-of ... The chance of survival significantly increases to 50%-74% when immediate defibrillation with an on-site AED is available [2,3-4]. In recent ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05013333

Study Details | NCT05013333 | AED 3 Post-Approval Study It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823184

Defibrillator Pad Position and Shockable Cardiac Arrest In this cohort study of patients with OHCA and VF or pVT, AP defibrillator pad placement was associated with higher ROSC compared with AL placement.

5. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4141290

The Role of Automated External Defibrillator Use in the Out ... Results: Thirty studies met inclusion criteria. PAD deployment significantly improved survival outcomes, with better results observed in public ...

6. americanaed.com americanaed.com/wp-content/uploads/ZOLL-AED-3-Spec-Sheet.pdf?srsltid=AfmBOopU3_a5pYfGM6T7Rf7Aqe0sSE3_4ZBjW8S6WwL2X7qFmWFkbGSD

Technical Specifications Enhanced Real CPR Help. The ZOLL AED 3™ automated external defibrillator (AED) provides detailed CPR guidance with proprietary. Real CPR Help® technology.

7. medidyne.dk medidyne.dk/wp-content/uploads/2022/10/ENG-AED-3-BLS-Specs.pdf

Technical Specifications The ZOLL AED 3 BLS provides enhanced Real CPR Help®, which measures the actual depth and rate of each compression and displays it numerically on the CPR ...

8. aedbrands.com aedbrands.com/blog/zoll-aed-3-features-review/?srsltid=AfmBOop1fNaiwIFLxfkXJqrupPDbZ82RFpw_8HJ89T7LsbPP7TTdj2jG

ZOLL AED 3 Features & Review The ZOLL AED 3 leads the way with Real CPR Help® technology, which provides real-time feedback to guide rescuers in delivering high-quality CPR.