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AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute" (DEFI2005)

Primary Purpose

Heart Arrest, Ventricular Fibrillation

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
One shock per minute AED protocol
Guidelines 2000 AED protocol
Sponsored by
Fire Brigade Of Paris Emergency Medicine Dept
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Arrest focused on measuring human, ventricular fibrillation, out-of-hospital, cardiac arrest, automated external defibrillators (AED), defibrillators, electrick countershock, cardiopulmonary resuscitation

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fire Brigade of Paris Emergency medicine department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CONTROL

STUDY

Arm Description

AED Treatment protocol following AHA Guidelines 2000 recommendations for cardiac arrest resuscitation.

AED treatment protocol with prolonged CPR intervals, single shocks, fewer rhythm analysis and pulse checks.

Outcomes

Primary Outcome Measures

the number of patients appropriately shocked by AED admitted alive at hospital / the total number of patients appropriately shocked by AED

Secondary Outcome Measures

Concerning patients appropriately shocked by AED: - return of spontaneous circulation (ROSC) at the arrival of physician on the scene
- ROSC within the first 8 minutes after the connection of the AED
- Patient survival determined throughout the followup period of 1 year post-arrest.
Safety endpoints were occurrences of CPR-related hemothorax requiring thoracic drain and/or hemorrhagic lesions requiring transfusion
Concerning patients not shocked by AED: - ROSC within the first 8 minutes after the connection of the AED
- patient admitted alive to the hospital

Full Information

First Posted
August 29, 2005
Last Updated
May 8, 2009
Sponsor
Fire Brigade Of Paris Emergency Medicine Dept
Collaborators
Brigade de Sapeurs Pompiers de Paris, Physio-Control, Inc, A division of Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00139542
Brief Title
AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
Acronym
DEFI2005
Official Title
Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fire Brigade Of Paris Emergency Medicine Dept
Collaborators
Brigade de Sapeurs Pompiers de Paris, Physio-Control, Inc, A division of Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: the importance of administering cardiac massage and artificial ventilation (CPR) prior to initiation of electrical shock treatment. the importance of continuing CPR immediately following electrical shock treatment the importance of reducing time between CPR procedures to a minimum the fact that three successive electrical shocks are of no therapeutic benefit. We want to compare the control algorithm with the new one titled "one shock per minute", for shocked patients. The sample size of this trial was calculated to provide a power of 85% and a type 1 error rate of alpha = 0.0294 for detecting an 11% increase in the rate of hospital admission, from its historical rate of 34% to a new rate of 45%. One interim analysis was planned with the stopping boundary alpha = 0.0294. This required inclusion of 430 patients in each group. The primary endpoint is defined as "the admission of the patient alive at the hospital". The secondary endpoints are defined as following : - Detection of Palpable Carotid Pulse (ROSC) within the first 8 minutes after the connection of the AED The other secondary endpoint is survival to one year. Concerning patients that do not receive shocks They represent a priori 82% of the patients. The absolute number is a priori 3940, that is to say, 1970 in both two groups. They will be used for an advanced observational descriptive study, to establish hypothesis for future studies.The same primary and secondary endpoints will be evaluated for them. Among these patients not shocked, the algorithm foresees 60 seconds of CPR for the Control Group, and 90 seconds for the Trial Group. This setting relies on the hypothesis that increasing the time dedicated to chest compressions will increase the probability of return of a palpable pulse (ROSC), even for patients who do not fibrillate. Statistical analysis will be completed by "Hôpital d'Instruction des Armées BEGIN - Epidemiology department" We propose a comparison using the Chi square test for qualitative variables, Student's t test for quantitative variables, completion of a logistics model to analyze prognostic factors, as well as the proportional hazards model for survival analysis. Tests will be bilateral (significant p = 0,029 if we consider one intermediate analysis). Overall analysis strategy will be defined and completed by the Epidemiology department of Hôpital d'Instruction des Armées BEGIN

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Arrest, Ventricular Fibrillation
Keywords
human, ventricular fibrillation, out-of-hospital, cardiac arrest, automated external defibrillators (AED), defibrillators, electrick countershock, cardiopulmonary resuscitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
AED Treatment protocol following AHA Guidelines 2000 recommendations for cardiac arrest resuscitation.
Arm Title
STUDY
Arm Type
Experimental
Arm Description
AED treatment protocol with prolonged CPR intervals, single shocks, fewer rhythm analysis and pulse checks.
Intervention Type
Other
Intervention Name(s)
One shock per minute AED protocol
Other Intervention Name(s)
Biphasic LIFEPAK(R) 500 AED with cprMAX technology
Intervention Description
Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.
Intervention Type
Other
Intervention Name(s)
Guidelines 2000 AED protocol
Other Intervention Name(s)
Biphasic LIFEPAK(R) 500 AED with cprMAX technology
Intervention Description
Up to 3 consecutive shocks in a stack; No initial CPR prior to the first shock; Post-shock pulse checks after each non-shockable rhythm analysis; 60 sec CPR after each non-shockable rhythm analysis.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Concerning patients appropriately shocked by AED: - return of spontaneous circulation (ROSC) at the arrival of physician on the scene
Time Frame
within the first hour after the first cardiac arrest
Title
- ROSC within the first 8 minutes after the connection of the AED
Time Frame
within the 8 minutes after the connection of the AED
Title
- Patient survival determined throughout the followup period of 1 year post-arrest.
Time Frame
one year after cardiac arrest
Title
Safety endpoints were occurrences of CPR-related hemothorax requiring thoracic drain and/or hemorrhagic lesions requiring transfusion
Time Frame
within days of the cardiac arrest
Title
Concerning patients not shocked by AED: - ROSC within the first 8 minutes after the connection of the AED
Time Frame
day of the cardiac arrest
Title
- patient admitted alive to the hospital
Time Frame
within 24-48 hours of the cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jost Daniel, Doctor
Organizational Affiliation
Fire Brigade of Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fire Brigade of Paris Emergency medicine department
City
Paris
ZIP/Postal Code
75017
Country
France

12. IPD Sharing Statement

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Citation
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Links:
URL
http://www.amspp.org
Description
click here for more information " étude clinique DEFI 2005 "
URL
http://www.pompiersparis.fr
Description
This is the official Paris Fire Brigade website

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AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"

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