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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure (at time of device placement)
Awards & highlights
Study Summary
This trial tests a new CPR sensor that is placed on the chest to deliver an electric shock to restart the heart. The sensor is tested on both adults and children.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed for this device trial, generally using an AED may cause skin burns or underlying tissue damage at the site where pads are placed. Rarely it might also affect heart rhythms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedure (at time of device placement)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure (at time of device placement)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CPR sensor placement
Selection of adult or pediatric mode
Trial Design
1Treatment groups
Experimental Treatment
Group I: AED 3 with Uni-padzExperimental Treatment1 Intervention
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Who is running the clinical trial?
Zoll Medical CorporationLead Sponsor
41 Previous Clinical Trials
21,983 Total Patients Enrolled
4 Trials studying Cardiac Arrest
12,231 Patients Enrolled for Cardiac Arrest
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Eligibility Criteria:
This trial includes the following eligibility 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.Your body shows no signs of blood circulation.You have a "Do Not Attempt Resuscitation" (DNAR) order in place.You have not experienced a heart attack.There is a suspicion that you had a cardiac arrest outside of a hospital.
Research Study Groups:
This trial has the following groups:- Group 1: AED 3 with Uni-padz
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for participants in this experiment?
"It appears this medical trial is not currently open to recruitment, according to the information hosted on clinicaltrials.gov. The study was initially made available on March 30th 2021 and its last update occured January 26th 2022; however, there are 32 other trials that require patients at present."
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