Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute" - Full Text View

Sponsored by:	FIRE BRIGADE OF PARIS EMERGENCY MEDICINE DEPT
Information provided by:	FIRE BRIGADE OF PARIS EMERGENCY MEDICINE DEPT
ClinicalTrials.gov Identifier:	NCT00139542

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	Device: Automated external defibrillator	Phase III

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: CPR Fires

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"

Further study details as provided by FIRE BRIGADE OF PARIS EMERGENCY MEDICINE DEPT:

Primary Outcome Measures:

the number of patients shocked by AED admitted alive at hospital / the total number of patients shocked by AED [ Time Frame: within the first day after the first cardiac arrest ]

Secondary Outcome Measures:

Concerning patients 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 ]
- ROSC within the first 8 minutes after the connection of the AED [ Time Frame: within the 8 minutes after the connection of the AED ]
- presence of organized electrical complexes on the AED trace, within the 8 minutes after the connection of the AED [ Time Frame: within the 8 minutes after the connection of the AED ]
- patient alive at the 24th, 48th hour of hospitalisation [ Time Frame: within the two days after cardiac arrest ]
- patient alive at the 10th, 15th day of hospitalisation [ Time Frame: within the 15 days after the first cardiac arrest ]
- patient discharged out of hospital [ Time Frame: within the 6 months after first cardiac arrest ]
- patient sent back home [ Time Frame: within the 6 months after the first cardiac arrest ]
Concerning patients not shocked by AED: - ROSC at the arrival of physician on the scene
- ROSC within the first 8 minutes after the connection of the AED
- presence of organized electrical complexes on the AED trace, within the 8 minutes after the connection of the AED
- patient alive at the 24th, 48th hour of hospitalisation
- patient alive at the 10th, 15th day of hospitalisation
- patient discharged out of hospital
- patient sent back home

Estimated Enrollment:	4800
Study Start Date:	September 2005
Estimated Study Completion Date:	September 2007

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

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

Investigators

Principal Investigator:

Jost Daniel, Doctor

Fire Brigade of Paris

More Information

click here for more information " étude clinique DEFI 2005 " This link exits the ClinicalTrials.gov site

This is the official Paris Fire Brigade website This link exits the ClinicalTrials.gov site

Publications:

Carpenter J, Rea TD, Murray JA, Kudenchuk PJ, Eisenberg MS. Defibrillation waveform and post-shock rhythm in out-of-hospital ventricular fibrillation cardiac arrest. Resuscitation. 2003 Nov;59(2):189-96.

van Alem AP, Sanou BT, Koster RW. Interruption of cardiopulmonary resuscitation with the use of the automated external defibrillator in out-of-hospital cardiac arrest. Ann Emerg Med. 2003 Oct;42(4):449-57.

Van Alem, Sanou, Koster. Police and fire service : intervall voice prompt to start CPR. Ann Emerg Med 2003; 42:449

Eisenberg MS, Horwood BT, Cummins RO, Reynolds-Haertle R, Hearne TR. Cardiac arrest and resuscitation: a tale of 29 cities. Ann Emerg Med. 1990 Feb;19(2):179-86.

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.

Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett PJ, Becker L, Bossaert L, Delooz HH, Dick WF, Eisenberg MS, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. A statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Circulation. 1991 Aug;84(2):960-75. Review. No abstract available.

Halawa B. [Treatment of cardiac arrhythmia in pregnant women] Pol Merkuriusz Lek. 2000 Aug;9(50):513-8. Polish.

Sato Y, Weil MH, Sun S, Tang W, Xie J, Noc M, Bisera J. Adverse effects of interrupting precordial compression during cardiopulmonary resuscitation. Crit Care Med. 1997 May;25(5):733-6.

Cobb LA, Fahrenbruch CE, Walsh TR, Copass MK, Olsufka M, Breskin M, Hallstrom AP. Influence of cardiopulmonary resuscitation prior to defibrillation in patients with out-of-hospital ventricular fibrillation. JAMA. 1999 Apr 7;281(13):1182-8.

Wik L, Hansen TB, Fylling F, Steen T, Vaagenes P, Auestad BH, Steen PA. Delaying defibrillation to give basic cardiopulmonary resuscitation to patients with out-of-hospital ventricular fibrillation: a randomized trial. JAMA. 2003 Mar 19;289(11):1389-95.

Berg RA, Hilwig RW, Kern KB, Ewy GA. Precountershock cardiopulmonary resuscitation improves ventricular fibrillation median frequency and myocardial readiness for successful defibrillation from prolonged ventricular fibrillation: a randomized, controlled swine study. Ann Emerg Med. 2002 Dec;40(6):563-70.

Eftestol T, Sunde K, Steen PA. Effects of interrupting precordial compressions on the calculated probability of defibrillation success during out-of-hospital cardiac arrest. Circulation. 2002 May 14;105(19):2270-3.

Study ID Numbers:	BSPP01092005
Study First Received:	August 29, 2005
Last Updated:	June 5, 2007
ClinicalTrials.gov Identifier:	NCT00139542
Health Authority:	France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:

Heart Diseases
Shock
Paroxysmal ventricular fibrillation

Heart Arrest
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009