DEFI2005: AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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:
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the importance of administering cardiac massage and artificial ventilation (CPR) prior to initiation of electrical shock treatment.
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the importance of continuing CPR immediately following electrical shock treatment
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the importance of reducing time between CPR procedures to a minimum
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- - patient admitted alive to the hospital [within 24-48 hours of the cardiac arrest]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients in a state of apparent death as noted on arrival of the emergency care team vehicle
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Resuscitation by first aid team with a minimum of three people
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Analysis of cardiac rhythm by the AED possible
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At least one appropriate shock delivered by the AED
Exclusion Criteria:
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Many victims (>3) that must be treated simultaneously
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Signs of certain death (lividity)
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Patient with palpable pulse on arrival of emergency care team
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Patient already connected to another device
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Incident involving an AED that requires a "materiovigilance" report
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Banville I, Walker RG, Chapman FW. Maximizing CPR by changing the AED configuration. IICE2005 Book of Abstracts; p 26.
- 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.
- 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.
- 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.
- 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.
- 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. Review.
- Eftestøl 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.
- 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.
- Halawa B. [Treatment of cardiac arrhythmia in pregnant women]. Pol Merkur Lekarski. 2000 Aug;9(50):513-8. Polish.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- BSPP01092005