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

NCT00139542 | Completed Phase 3 DMC

• 1 other identifier: BSPP01092005
• Study Type: interventional
• Target: 5,107
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Arrest; Ventricular Fibrillation

Keywords

human; ventricular fibrillation; out-of-hospital; cardiac arrest; automated external defibrillators (AED); defibrillators; electrick countershock; cardiopulmonary resuscitation

Outcome Measures

Primary Outcomes (1)

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

  within the first day after the first cardiac arrest

Secondary Outcomes (6)

• 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

• - ROSC within the first 8 minutes after the connection of the AED

  within the 8 minutes after the connection of the AED

• - Patient survival determined throughout the followup period of 1 year post-arrest.

  one year after 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

• Concerning patients not shocked by AED: - ROSC within the first 8 minutes after the connection of the AED

  day of the cardiac arrest

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

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

Other: Guidelines 2000 AED protocol

STUDY

EXPERIMENTAL

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

Other: One shock per minute AED protocol

Interventions

One shock per minute AED protocol OTHER

Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.

Also known as: Biphasic LIFEPAK(R) 500 AED with cprMAX technology

STUDY

Guidelines 2000 AED protocol OTHER

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.

Also known as: Biphasic LIFEPAK(R) 500 AED with cprMAX technology

CONTROL

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fire Brigade Of Paris Emergency Medicine Dept: lead
• Brigade de Sapeurs Pompiers de Paris: collaborator
• Physio-Control, Inc, A division of Medtronic: collaborator

Study Sites (1)

Fire Brigade of Paris Emergency medicine department

Paris, 75017, France

Location

Related Publications (22)

• 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. doi: 10.1016/s0300-9572(03)00183-7.

  PMID: 14625109 BACKGROUND

• 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. doi: 10.1067/s0196-0644(03)00383-4.

  PMID: 14520315 BACKGROUND

• 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. doi: 10.1016/s0196-0644(05)81805-0.

  PMID: 2301797 BACKGROUND

• Cummins RO, Ornato JP, Thies WH, Pepe PE. Improving survival from sudden cardiac arrest: the "chain of survival" concept. A statement for health professionals from the Advanced Cardiac Life Support Subcommittee and the Emergency Cardiac Care Committee, American Heart Association. Circulation. 1991 May;83(5):1832-47. doi: 10.1161/01.cir.83.5.1832. No abstract available.

  PMID: 2022039 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1161/01.cir.84.2.960. No abstract available.

  PMID: 1860248 BACKGROUND

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

  PMID: 11081313 BACKGROUND

• 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. doi: 10.1097/00003246-199705000-00005.

  PMID: 9187589 BACKGROUND

• 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. doi: 10.1001/jama.281.13.1182.

  PMID: 10199427 BACKGROUND

• 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. doi: 10.1001/jama.289.11.1389.

  PMID: 12636461 BACKGROUND

• 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. doi: 10.1067/mem.2002.129866.

  PMID: 12447331 BACKGROUND

• 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. doi: 10.1161/01.cir.0000016362.42586.fe.

  PMID: 12010909 BACKGROUND

• Banville I, Walker RG, Chapman FW. Maximizing CPR by changing the AED configuration. IICE2005 Book of Abstracts; p 26.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  RESULT

• 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

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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).

  RESULT

• 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

  RESULT

• Jost D, Degrange H, Verret C, Hersan O, Banville IL, Chapman FW, Lank P, Petit JL, Fuilla C, Migliani R, Carpentier JP; DEFI 2005 Work Group. DEFI 2005: a randomized controlled trial of the effect of automated external defibrillator cardiopulmonary resuscitation protocol on outcome from out-of-hospital cardiac arrest. Circulation. 2010 Apr 13;121(14):1614-22. doi: 10.1161/CIRCULATIONAHA.109.878389. Epub 2010 Mar 29.

  PMID: 20351239 DERIVED

Related Links

• This is the official Paris Fire Brigade website

MeSH Terms

Conditions

Heart Arrest; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jost Daniel, Doctor

  Fire Brigade of Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: September 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: June 1, 2008
• Last Updated: May 11, 2009

Record last verified: 2009-05

Locations

FR (1)