Heart ArrestPhase 3DEFI2005NCT00139542
AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
A Phase 3 study testing One shock per minute AED protocol and Guidelines 2000 AED protocol in people with Heart Arrest and Ventricular Fibrillation, run by Fire Brigade Of Paris Emergency Medicine Dept at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Heart Arrest, Ventricular Fibrillation
- What is being tested?
- One shock per minute AED protocol and Guidelines 2000 AED protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,107 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
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.
Read the 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
- Conditions
- Heart Arrest, Ventricular Fibrillation
- Being tested
- One shock per minute AED protocol, Guidelines 2000 AED protocol
- Keywords
- human, ventricular fibrillation, out-of-hospital, cardiac arrest, automated external defibrillators (AED), defibrillators, electrick countershock, cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One shock per minute AED protocolOther
Also called Biphasic LIFEPAK(R) 500 AED with cprMAX technology
Single shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery.
Guidelines 2000 AED protocolOther
Also called Biphasic LIFEPAK(R) 500 AED with cprMAX technology
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | AED Treatment protocol following AHA Guidelines 2000 recommendations for cardiac arrest resuscitation. Receives: Other: Guidelines 2000 AED protocol |
| STUDY | Experimental | AED treatment protocol with prolonged CPR intervals, single shocks, fewer rhythm analysis and pulse checks. Receives: Other: One shock per minute AED protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients appropriately shocked by AED admitted alive at hospital / the total number of patients appropriately shocked by AED
Measured: 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
Measured: within the first hour after the first cardiac arrest
- ROSC within the first 8 minutes after the connection of the AED
Measured: within the 8 minutes after the connection of the AED
- Patient survival determined throughout the followup period of 1 year post-arrest.
Measured: one year after cardiac arrest
Safety endpoints were occurrences of CPR-related hemothorax requiring thoracic drain and/or hemorrhagic lesions requiring transfusion
Measured: within days of the cardiac arrest
Concerning patients not shocked by AED: - ROSC within the first 8 minutes after the connection of the AED
Measured: day of the cardiac arrest
- patient admitted alive to the hospital
Measured: within 24-48 hours of the cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fire Brigade Of Paris Emergency Medicine Dept
- Sponsor type
- University, hospital or other
- Collaborators
- Brigade de Sapeurs Pompiers de Paris, Physio-Control, Inc, A division of Medtronic
- Investigators
- Jost Daniel, Doctor, Principal investigator, Fire Brigade of Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139542
- Sponsor's protocol ID
- BSPP01092005
- Acronym
- DEFI2005
- Status last verified
- May 2009
- First submitted
- 29 Aug 2005
- Last updated
- 11 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/s0300-9572(03)00183-7.
PubMed 14625109van 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.
PubMed 14520315Eisenberg 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.
PubMed 2301797Cummins 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.
PubMed 2022039Jost 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. doi: 10.1161/01.cir.84.2.960. No abstract available.
PubMed 1860248Halawa B. [Treatment of cardiac arrhythmia in pregnant women]. Pol Merkur Lekarski. 2000 Aug;9(50):513-8. Polish.
PubMed 11081313Sato 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.
PubMed 9187589Cobb 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.
PubMed 10199427Wik 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.
PubMed 12636461Berg 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.
PubMed 12447331Eftestol 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.
PubMed 12010909Banville 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated External Defibrillator (AED) Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"
- ClinicalTrials.gov ID
- NCT00139542
- Acronym / sponsor ID
- DEFI2005 / BSPP01092005
- Conditions
- Heart Arrest, Ventricular Fibrillation
- Keywords
- human, ventricular fibrillation, out-of-hospital, cardiac arrest, automated external defibrillators (AED), defibrillators, electrick countershock, cardiopulmonary resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,107 participants (actual)
- Lead sponsor
- Fire Brigade Of Paris Emergency Medicine DeptUniversity, hospital or other
- Collaborators
- Brigade de Sapeurs Pompiers de Paris, Physio-Control, Inc, A division of Medtronic
- Study start
- Sep 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Other: Guidelines 2000 AED protocolAED Treatment protocol following AHA Guidelines 2000 recommendations for cardiac arrest resuscitation. |
| STUDY | Experimental | Other: One shock per minute AED protocolAED treatment protocol with prolonged CPR intervals, single shocks, fewer rhythm analysis and pulse checks. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One shock per minute AED protocolAlso: Biphasic LIFEPAK(R) 500 AED with cprMAX technologySingle shocks; No post-shock pulse checks; 60 sec CPR before first shock; 30 sec CPR between rhythm analysis and shock delivery. | Other | STUDY |
| Guidelines 2000 AED protocolAlso: Biphasic LIFEPAK(R) 500 AED with cprMAX technologyUp 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 | CONTROL |
Primary outcome
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
6 secondary outcomes
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
- ROSC within the first 8 minutes after the connection of the AED
Time frame: within the 8 minutes after the connection of the AED
- Patient survival determined throughout the followup period of 1 year post-arrest.
Time frame: one year after cardiac arrest
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
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
- patient admitted alive to the hospital
Time frame: within 24-48 hours of the cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2009.
- Background: PubMed 14625109Carpenter 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.
- Background: PubMed 14520315van 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.
- Background: PubMed 2301797Eisenberg 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.
- Background: PubMed 2022039Cummins 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.
- BackgroundJost 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: PubMed 1860248Cummins 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.
- Background: PubMed 11081313Halawa B. [Treatment of cardiac arrhythmia in pregnant women]. Pol Merkur Lekarski. 2000 Aug;9(50):513-8. Polish.
- Background: PubMed 9187589Sato 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.
- Background: PubMed 10199427Cobb 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.
- Background: PubMed 12636461Wik 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.
- Background: PubMed 12447331Berg 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.
- Background: PubMed 12010909Eftestol 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.
- This is the official Paris Fire Brigade websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jost Daniel, Doctor principal investigator
Fire Brigade of Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing One shock per minute AED protocol and Guidelines 2000 AED protocol in people with Heart Arrest and Ventricular Fibrillation, run by Fire Brigade Of Paris Emergency Medicine Dept at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139542, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2009.