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

This study has been completed.
Sponsor:
Collaborators:
Brigade de Sapeurs Pompiers de Paris
Physio-Control, Inc, A division of Medtronic
Information provided by:
Fire Brigade Of Paris Emergency Medicine Dept
ClinicalTrials.gov Identifier:
NCT00139542
First received: August 29, 2005
Last updated: May 8, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Heart Arrest
Ventricular Fibrillation
Other: One shock per minute AED protocol
Other: Guidelines 2000 AED protocol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"

Resource links provided by NLM:


Further study details as provided by Fire Brigade Of Paris Emergency Medicine Dept:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • - ROSC within the first 8 minutes after the connection of the AED [ Time Frame: within the 8 minutes after the connection of the AED ] [ Designated as safety issue: No ]
  • - Patient survival determined throughout the followup period of 1 year post-arrest. [ Time Frame: one year after cardiac arrest ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • - patient admitted alive to the hospital [ Time Frame: within 24-48 hours of the cardiac arrest ] [ Designated as safety issue: No ]

Enrollment: 5107
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CONTROL
AED Treatment protocol following AHA Guidelines 2000 recommendations for cardiac arrest resuscitation.
Other: Guidelines 2000 AED protocol
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.
Other Name: Biphasic LIFEPAK(R) 500 AED with cprMAX technology
Experimental: STUDY
AED treatment protocol with prolonged CPR intervals, single shocks, fewer rhythm analysis and pulse checks.
Other: One shock per minute AED protocol
Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.
Other Name: Biphasic LIFEPAK(R) 500 AED with cprMAX technology

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139542

Locations
France
Fire Brigade of Paris Emergency medicine department
Paris, France, 75017
Sponsors and Collaborators
Fire Brigade Of Paris Emergency Medicine Dept
Brigade de Sapeurs Pompiers de Paris
Physio-Control, Inc, A division of Medtronic
Investigators
Principal Investigator: Jost Daniel, Doctor Fire Brigade of Paris
  More Information

Additional Information:
Publications:
Hersan O, Jost D, Banville IL et al. More CPR With the New Guidelines. Does It Impact VF Termination by Defibrillation Shocks? [abstr]. Circulation 2007;116:II_386-a.
Jost D, Degrange H, Hersan O, Briche F, Fontaine D, Lallement D, Calamai F, Verret C, Banville I, Chapman F, Koster R, Descatha A, Petit J-L, Fuilla C. Prospective Clinical Trial, DEFI 2005: Does an AED Algorithm with More CPR Impact Out-of-Hospital Cardiac Arrest Prognosis? Resuscitation 2008;77 (Supp 1):.S18. (Abstract). ERC 2008
Jost D, Banville I, Degrange H, Hersan O, Briche F, Dubourdieu S, Fontaine D, Lallement D, Chapman F, Lank P, Petit J-L, Fuilla C. Metronome Use to Improve CPR by Firefighters during Out-of-Hospital Cardiac Arrest. Academic Emergency Medicine 2008;15(s1):S21-S22. (Abstract). SAEM 2008.
Jost D, Degrange H, Hersan O, Briche F, Fontaine D, Lallement D, Calamai F, Verret C, Banville I, Chapman F, Koster R, Fuilla C, Jost D, Descatha A, Dubourdieu S, Petit J-L, Lank P. Prospective Clinical Trial, DEFI 2005: Does an AED Algorithm with More CPR Impact Out-of-Hospital Cardiac Arrest Prognosis? Academic Emergency Medicine 2008;15(s1):S224-S225. (Abstract). SAEM 2008.
Jost D, Banville I, Girardeau S, Calamai F, Fontaine D, Lallement D, Chapman FW, Degrange H, Petit J-L, Fuilla C. Impact of reducing CPR hands-off time during out-of-hospital cardiac arrest on post-shock rhythm progression. Eur Heart J. 2008;29:642 (Abstract).
Jost D, Degrange H, Banville IL, Hersan O, Briche F, Fontaine D, Lallement D, Calamai F, Chapman FW, Petit J-L, Fuilla C. Is the Outcome from Witnessed VF Cardiac Arrest Improved by Providing More CPR? Results from DEFI2005, a Randomized Controlled Trial of two AED Protocols. Circulation. 2008;118:S_1447. (Abstract). AHA 2008
Jost D, Richter F, Morell E, Michel A, Goldstein P, Petit P et al. Expérience française de la défibrillation semi-automatique. Jeur, 1998;3:1A24-131.
Banville I, Walker RG, Chapman FW. Maximizing CPR by changing the AED configuration. IICE2005 Book of Abstracts; p 26.
Jost D, Calamai F, Fontaine D et al. Concordance Between Carotid Pulse Check and Transthoracic Impedance Characteristics in Out-of-Hospital Cardiac Arrest [abstr]. Circulation 2006;114:II_1201-a.
Renard A, Jost D, Verret C et al. Effect of Thrombolytics on the Immediate Prognosis for Out-of-Hospital Cardiac Arrest [abstr]. Circulation 2007;116:II_928-b.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Jost, MD, Brigade de Sapeurs Pompiers de Paris
ClinicalTrials.gov Identifier: NCT00139542     History of Changes
Other Study ID Numbers: BSPP01092005
Study First Received: August 29, 2005
Last Updated: May 8, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Fire Brigade Of Paris Emergency Medicine Dept:
human
ventricular fibrillation
out-of-hospital
cardiac arrest
automated external defibrillators (AED)
defibrillators
electrick countershock
cardiopulmonary resuscitation

Additional relevant MeSH terms:
Heart Arrest
Ventricular Fibrillation
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014