Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 5,107
- Locations
- 2
- Primary Endpoint
- the number of patients appropriately shocked by AED admitted alive at hospital / the total number of patients appropriately shocked by AED
Study Overview
Brief Summary
The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock, and the time devoted to chest compressions.
The researchers propose to decrease the periods of interruption of cardiopulmonary resuscitation (CPR), while keeping the principle of early defibrillation.
Detailed Description
Early use of semi-automated external defibrillators (AED) by Emergency Care teams in out-of-hospital cardiac arrest (OHCA), has been correlated with a significant gain in sequelae-free survival. The AED is programmed with an algorithm based recommended guidelines.
We will test a new algorithm that takes into account recent findings in pathophysiology.
Patients presenting with cardiovascular and pulmonary arrest treated by the BSPP Emergency Care who meet inclusion criterion are proposed for inclusion in the trial.
The aim of the trial is to evaluate a new AED algorithm that proposes a new timeline between the time devoted to administer a defibrillation shock, and the time devoted to chest compressions.
The new algorithm is entitled "one shock per minute". Use of this algorithm should validate several hypotheses:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients in a state of apparent death as noted on arrival of the emergency care team vehicle
- •Resuscitation by first aid team with a minimum of three people
- •Analysis of cardiac rhythm by the AED possible
- •At least one appropriate shock delivered by the AED
Exclusion Criteria
- •Many victims (>3) that must be treated simultaneously
- •Signs of certain death (lividity)
- •Patient with palpable pulse on arrival of emergency care team
- •Patient already connected to another device
- •Incident involving an AED that requires a "materiovigilance" report
Outcomes
Primary Outcomes
the number of patients appropriately shocked by AED admitted alive at hospital / the total number of patients appropriately shocked by AED
Time Frame: within the first day after the first cardiac arrest
Secondary Outcomes
- Concerning patients appropriately shocked by AED: - return of spontaneous circulation (ROSC) at the arrival of physician on the scene(within the first hour after the first cardiac arrest)
- Safety endpoints were occurrences of CPR-related hemothorax requiring thoracic drain and/or hemorrhagic lesions requiring transfusion(within days of the cardiac arrest)
- - patient admitted alive to the hospital(within 24-48 hours of the cardiac arrest)
- - ROSC within the first 8 minutes after the connection of the AED(within the 8 minutes after the connection of the AED)
- Concerning patients not shocked by AED: - ROSC within the first 8 minutes after the connection of the AED(day of the cardiac arrest)
- - Patient survival determined throughout the followup period of 1 year post-arrest.(one year after cardiac arrest)