Ventricular FibrillationSmartCPRNCT00535106
SmartCPR Trial: An Analysis of a Waveform-Based Automated External Defibrillation (AED) Algorithm on Survival From Out-of-Hospital Ventricular Fibrillation
A study testing Automated external defibrillator (Philips FR2+ AED), SmartCPR and Delayed defibrillation in people with Ventricular Fibrillation and Cardiac Arrest, run by New York City Fire Department at 2 sites in 2 countries.
Trial summary
This study is designed to examine the impact of an available technology within an automated external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest for patients presenting in ventricular fibrillation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventricular Fibrillation, Cardiac Arrest
- What is being tested?
- Automated external defibrillator (Philips FR2+ AED), SmartCPR and Delayed defibrillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2006to Jun 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- initial treatment includes application of a study AED
- complete initial waveform analysis
- presenting rhythm is ventricular fibrillation
- arrest of cardiac etiology
Who cannot join
- arrest of noncardiac etiology
- initial treatment with a non-study defibrillator
- missing AED data
- age <18 (London only)
- resuscitation terminated due to a DNR order / decision
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
New York City Fire Department
New York, New York, 11201
About this study
Official title: An International, Randomized, Controlled Prehospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation
This study is designed to examine the impact of an available technology within an automated external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest for patients presenting in ventricular fibrillation.
Read the detailed description
The delivery of an electrical shock, termed defibrillation, has long been recognized as one of the critical "links" in the "Chain of Survival" following out-of-hospital cardiac arrest. This is particularly the case for patients who present in ventricular fibrillation (VF), a state of constant and yet uncoordinate firing of the lower portions of the heart (the ventricles), and the ability to treat these patients with defibrillation prior to their arrival in the hospital has remained one of the reasons why this group represents the patients who are most likely to survive an out-of-hospital cardiac arrest.
Though this technology has been successfully utilized in the prehospital setting for more than forty years, the long-held belief that "immediate defibrillation" was the optimal treatment for all patients has now come into question.
Following research done in locations such as Seattle, WA and Oslo, Norway, there came a recognition that some patients (particularly those who have been in cardiac arrest for 4-5 minutes prior to EMS arrival) may actually benefit from a period of CPR prior to defibrillation ("delayed defibrillation"). This has to do with the changes that take place within the heart and even at the level of the cells within the heart following the onset of VF. After several minutes of VF, the cells within the heart have been deprived and depleted of oxygen and other energy-containing molecules, and there has been a build-up of other substances such as acids and potassium. By providing CPR prior to defibrillation, it is thought that the patient's heart may be provided with enough oxygen and other energy-containing molecules, making it more likely that the heart will respond favorably to defibrillation.
Yet this is not necessarily true for all VF patients. Other data from patients whose collapse and cardiac arrest were witnessed and for whom defibrillation was able to be provided quite rapidly (i.e. those in airports, airplanes, and casinos) demonstrate a very high survival rate when compared to those patients who have been in arrest for a longer period. This suggests that there are patients who are best treated with immediate defibrillation and those who are treated with "delayed defibrillation."
The problems for modern emergency medical services (EMS) systems include determining just when the VF began, the impact of bystander CPR, the patient's overall condition at the time of the cardiac arrest, and the time interval from the 911 call until the arrival of the EMS providers (EMTs and paramedics) at the side of the patient.
By choosing to provide immediate defibrillation to all patients, in hopes of benefiting those who are most likely to respond to defibrillation and to survive, an EMS system would simultaneously be choosing to provide less than ideal treatment to those patients who are likely to benefit from "delayed defibrillation." Conversely, choosing to provide "delayed defibrillation" to all patients likely treats the larger percentage of VF patients in any EMS system appropriately, yet it potentially delays life-saving treatment from those who are most likely to survive (the patients who would benefit from immediate defibrillation).
Research involving the mathematic properties of the VF waveform (something that the human eye cannot calculate) have led to the development of computer algorithms that may predict, based on the calculated mathematical "score" of the VF, whether a patient is likely to respond more favorably to immediate defibrillation or delayed defibrillation. Such a technology could, therefore, seem to be able to recommend every patient to the treatment that is best for their individual condition, and it would follow that such individual treatment may improve survival from VF cardiac arrest overall.
This study is designed to examine the effect of just such a technology on VF patients presenting to EMS providers in New York, NY and London, England.
- Conditions
- Ventricular Fibrillation, Cardiac Arrest
- Being tested
- Automated external defibrillator (Philips FR2+ AED), SmartCPR, Delayed defibrillation
- Keywords
- Ventricular fibrillation, Cardiac arrest, Automated external defibrillator, AED, Waveform based algorithms, VF waveform analysis
- Medical subject headings
- Ventricular Fibrillation, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated external defibrillator (Philips FR2+ AED)Device
Also called Philips FR2+ AED
Patients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts.
SmartCPRDevice
Patient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient.
Delayed defibrillationOther
In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Standard resusc | Active comparator | Patients in this arm will be treated with standard resuscitation efforts, including the delivery of an immediate defibrillatory shock for all patients presenting in VF. Receives: Device: Automated external defibrillator (Philips FR2+ AED) |
| SmartCPR | Experimental | Patient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient. Receives: Device: SmartCPR |
| Delayed defib | Active comparator | In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation. Data is being collected on this population as well, thereby providing a cohort population for comparative purposes. Receives: Other: Delayed defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to Hospital Discharge
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Secondary outcomes (18)
Survival to hospital admission
Measured: within hours from the time of arrest
Return of spontaneous circulation (ROSC) in prehospital setting
Measured: Variable (depends on EMS contact time)
Neurological status among survivors
Measured: Variable (measured at hospital discharge)
Survival (defined as ROSC, survival to hospital admission, and survival to hospital discharge) as compared to a "delayed defibrillation" cohort in NYC
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Impact of CPR interval on VF waveform characteristics
Measured: Immediately after CPR interval
Utility of AED algorithm and VF characteristics among EMS-witnessed arrests
Measured: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge)
Utility of this AED technology and VF characteristics among pediatric patients
Measured: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge)
Impact of bystander CPR on VF waveform characteristics
Measured: Immediate (taken from data during arrest)
Comparison of EMS response times to VF waveform characteristics
Measured: Immediate (data obtained during EMS response and arrest period)
Frequency of unmanageable airways in out-of-hospital cardiac arrest patients
Measured: Immediate (measured at the time of arrest)
Impact of patient race upon the provision of bystander CPR, VF waveform characteristics, and survival
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Relationship between presenting and interval waveform capnography readings and survival
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Frequency of organ donation among out-of-hospital cardiac arrest patients transported to the hospital who do not survive to hospital discharge
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Waveform characteristics among patients presenting in secondary VF (initial presenting rhythm asystole or pulseless electrical activity)
Measured: Immediate (derived from data collected during the arrest)
Description of and outcomes of patients for whom intraosseous access is utilized during the cardiac arrest
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Utstein comparison of two cities (London and New York)
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Impact of bystander CPR on survival as a function of response time
Measured: Variable (depends upon interval needed for hospital admission and discharge)
Association between ambient small particle (PM2.5) pollution and cardiac arrest indicence in New York City
Measured: To be determined by modelling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startMay 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for Ventricular FibrillationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Fire Department
- Sponsor type
- Other government
- Collaborators
- Philips Medical Systems, London Ambulance Service
- Investigators
- John P Freese, MD, Principal investigator, New York City Fire DepartmentBradley J Kaufman, MD, MPH, Study director, New York City Fire DepartmentRachael Donohoe, PhD, Study director, London Ambulance ServiceDawn Jorgenson, PhD, Study director, Philips Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535106
- Sponsor's protocol ID
- H05290
- Acronym
- SmartCPR
- Status last verified
- Oct 2009
- First submitted
- 25 Sep 2007
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cobb LA, Fahrenbruch CE, Olsufka M, Copass MK. Changing incidence of out-of-hospital ventricular fibrillation, 1980-2000. JAMA. 2002 Dec 18;288(23):3008-13. doi: 10.1001/jama.288.23.3008.
PubMed 12479765Niemann JT, Cairns CB, Sharma J, Lewis RJ. Treatment of prolonged ventricular fibrillation. Immediate countershock versus high-dose epinephrine and CPR preceding countershock. Circulation. 1992 Jan;85(1):281-7. doi: 10.1161/01.cir.85.1.281.
PubMed 1728458Angelos MG, Stoner JD. Cardiopulmonary resuscitation, ventilation, defibrillation: in what order? Ann Emerg Med. 2002 Dec;40(6):571-4. doi: 10.1067/mem.2002.130130. No abstract available.
PubMed 12447332Valenzuela TD. Priming the pump--can delaying defibrillation improve survival after sudden cardiac death? JAMA. 2003 Mar 19;289(11):1434-6. doi: 10.1001/jama.289.11.1434. No abstract available.
PubMed 12636468Valenzuela TD, Roe DJ, Nichol G, Clark LL, Spaite DW, Hardman RG. Outcomes of rapid defibrillation by security officers after cardiac arrest in casinos. N Engl J Med. 2000 Oct 26;343(17):1206-9. doi: 10.1056/NEJM200010263431701.
PubMed 11071670Eftestol T, Losert H, Kramer-Johansen J, Wik L, Sterz F, Steen PA. Independent evaluation of a defibrillation outcome predictor for out-of-hospital cardiac arrested patients. Resuscitation. 2005 Oct;67(1):55-61. doi: 10.1016/j.resuscitation.2005.05.006.
PubMed 16154680Eftestol T, Wik L, Sunde K, Steen PA. Effects of cardiopulmonary resuscitation on predictors of ventricular fibrillation defibrillation success during out-of-hospital cardiac arrest. Circulation. 2004 Jul 6;110(1):10-5. doi: 10.1161/01.CIR.0000133323.15565.75. Epub 2004 Jun 21.
PubMed 15210599Wik 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 12636461Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002 Oct 17;347(16):1242-7. doi: 10.1056/NEJMoa020932.
PubMed 12393821Cobb 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 10199427Heightman AJ. Eagle Creek report: results of the 2-day consensus retreat on leading controversies in EMS. JEMS. 2004 Sep;29(9):suppl 7-9. No abstract available.
PubMed 15461996Snyder DE, White RD, Jorgenson DB. Outcome prediction for guidance of initial resuscitation protocol: Shock first or CPR first. Resuscitation. 2007 Jan;72(1):45-51. doi: 10.1016/j.resuscitation.2006.05.018. Epub 2006 Nov 14.
PubMed 17107744American Heart Association. 2005 American Heart Association (AHA) guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care (ECC) of pediatric and neonatal patients: pediatric basic life support. Pediatrics. 2006 May;117(5):e989-1004. doi: 10.1542/peds.2006-0219.
PubMed 16651298International Liaison Committee on Resuscitation. The International Liaison Committee on Resuscitation (ILCOR) consensus on science with treatment recommendations for pediatric and neonatal patients: pediatric basic and advanced life support. Pediatrics. 2006 May;117(5):e955-77. doi: 10.1542/peds.2006-0206. Epub 2006 Apr 17.
PubMed 16618790Hazinski MF, Nadkarni VM, Hickey RW, O'Connor R, Becker LB, Zaritsky A. Major changes in the 2005 AHA Guidelines for CPR and ECC: reaching the tipping point for change. Circulation. 2005 Dec 13;112(24 Suppl):IV206-11. doi: 10.1161/CIRCULATIONAHA.105.170809. Epub 2005 Nov 28. No abstract available.
PubMed 16314349
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Randomized, Controlled Prehospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation
- ClinicalTrials.gov ID
- NCT00535106
- Acronym / sponsor ID
- SmartCPR / H05290
- Conditions
- Ventricular Fibrillation, Cardiac Arrest
- Keywords
- Ventricular fibrillation, Cardiac arrest, Automated external defibrillator, AED, Waveform based algorithms, VF waveform analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- New York City Fire DepartmentOther government
- Collaborators
- Philips Medical Systems, London Ambulance Service
- Study start
- May 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Sep 2007 (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.
This study is designed to examine the impact of an available technology within an automated external defibrillator (AEDs) to improve survival following out-of-hospital cardiac arrest for patients presenting in ventricular fibrillation.
Detailed description
The delivery of an electrical shock, termed defibrillation, has long been recognized as one of the critical "links" in the "Chain of Survival" following out-of-hospital cardiac arrest. This is particularly the case for patients who present in ventricular fibrillation (VF), a state of constant and yet uncoordinate firing of the lower portions of the heart (the ventricles), and the ability to treat these patients with defibrillation prior to their arrival in the hospital has remained one of the reasons why this group represents the patients who are most likely to survive an out-of-hospital cardiac arrest.
Though this technology has been successfully utilized in the prehospital setting for more than forty years, the long-held belief that "immediate defibrillation" was the optimal treatment for all patients has now come into question.
Following research done in locations such as Seattle, WA and Oslo, Norway, there came a recognition that some patients (particularly those who have been in cardiac arrest for 4-5 minutes prior to EMS arrival) may actually benefit from a period of CPR prior to defibrillation ("delayed defibrillation"). This has to do with the changes that take place within the heart and even at the level of the cells within the heart following the onset of VF. After several minutes of VF, the cells within the heart have been deprived and depleted of oxygen and other energy-containing molecules, and there has been a build-up of other substances such as acids and potassium. By providing CPR prior to defibrillation, it is thought that the patient's heart may be provided with enough oxygen and other energy-containing molecules, making it more likely that the heart will respond favorably to defibrillation.
Yet this is not necessarily true for all VF patients. Other data from patients whose collapse and cardiac arrest were witnessed and for whom defibrillation was able to be provided quite rapidly (i.e. those in airports, airplanes, and casinos) demonstrate a very high survival rate when compared to those patients who have been in arrest for a longer period. This suggests that there are patients who are best treated with immediate defibrillation and those who are treated with "delayed defibrillation."
The problems for modern emergency medical services (EMS) systems include determining just when the VF began, the impact of bystander CPR, the patient's overall condition at the time of the cardiac arrest, and the time interval from the 911 call until the arrival of the EMS providers (EMTs and paramedics) at the side of the patient.
By choosing to provide immediate defibrillation to all patients, in hopes of benefiting those who are most likely to respond to defibrillation and to survive, an EMS system would simultaneously be choosing to provide less than ideal treatment to those patients who are likely to benefit from "delayed defibrillation." Conversely, choosing to provide "delayed defibrillation" to all patients likely treats the larger percentage of VF patients in any EMS system appropriately, yet it potentially delays life-saving treatment from those who are most likely to survive (the patients who would benefit from immediate defibrillation).
Research involving the mathematic properties of the VF waveform (something that the human eye cannot calculate) have led to the development of computer algorithms that may predict, based on the calculated mathematical "score" of the VF, whether a patient is likely to respond more favorably to immediate defibrillation or delayed defibrillation. Such a technology could, therefore, seem to be able to recommend every patient to the treatment that is best for their individual condition, and it would follow that such individual treatment may improve survival from VF cardiac arrest overall.
This study is designed to examine the effect of just such a technology on VF patients presenting to EMS providers in New York, NY and London, England.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard resusc | Active comparator | Device: Automated external defibrillator (Philips FR2+ AED)Patients in this arm will be treated with standard resuscitation efforts, including the delivery of an immediate defibrillatory shock for all patients presenting in VF. |
| SmartCPR | Experimental | Device: SmartCPRPatient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient. |
| Delayed defib | Active comparator | Other: Delayed defibrillationIn New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation. Data is being collected on this population as well, thereby providing a cohort population for comparative purposes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- initial treatment includes application of a study AED
- complete initial waveform analysis
- presenting rhythm is ventricular fibrillation
- arrest of cardiac etiology
Key exclusion criteria (5 listed)
- arrest of noncardiac etiology
- initial treatment with a non-study defibrillator
- missing AED data
- age <18 (London only)
- resuscitation terminated due to a DNR order / decision
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 |
|---|---|---|
| Automated external defibrillator (Philips FR2+ AED)Also: Philips FR2+ AEDPatients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts. | Device | Standard resusc |
| SmartCPRPatient in this arm will be treated with standard resuscitation efforts except that the first AED analysis will utilize an waveform-based algorithm to recommend either immediate defibrillation or delayed defibrillation for each patient. | Device | SmartCPR |
| Delayed defibrillationIn New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation. | Other | Delayed defib |
Primary outcome
Survival to Hospital Discharge
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
18 secondary outcomes
Survival to hospital admission
Time frame: within hours from the time of arrest
Return of spontaneous circulation (ROSC) in prehospital setting
Time frame: Variable (depends on EMS contact time)
Neurological status among survivors
Time frame: Variable (measured at hospital discharge)
Survival (defined as ROSC, survival to hospital admission, and survival to hospital discharge) as compared to a "delayed defibrillation" cohort in NYC
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Impact of CPR interval on VF waveform characteristics
Time frame: Immediately after CPR interval
Utility of AED algorithm and VF characteristics among EMS-witnessed arrests
Time frame: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge)
Utility of this AED technology and VF characteristics among pediatric patients
Time frame: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge)
Impact of bystander CPR on VF waveform characteristics
Time frame: Immediate (taken from data during arrest)
Comparison of EMS response times to VF waveform characteristics
Time frame: Immediate (data obtained during EMS response and arrest period)
Frequency of unmanageable airways in out-of-hospital cardiac arrest patients
Time frame: Immediate (measured at the time of arrest)
Impact of patient race upon the provision of bystander CPR, VF waveform characteristics, and survival
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Relationship between presenting and interval waveform capnography readings and survival
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Frequency of organ donation among out-of-hospital cardiac arrest patients transported to the hospital who do not survive to hospital discharge
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Waveform characteristics among patients presenting in secondary VF (initial presenting rhythm asystole or pulseless electrical activity)
Time frame: Immediate (derived from data collected during the arrest)
Description of and outcomes of patients for whom intraosseous access is utilized during the cardiac arrest
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Utstein comparison of two cities (London and New York)
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Impact of bystander CPR on survival as a function of response time
Time frame: Variable (depends upon interval needed for hospital admission and discharge)
Association between ambient small particle (PM2.5) pollution and cardiac arrest indicence in New York City
Time frame: To be determined by modelling
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 19 Oct 2009.
- Background: PubMed 12479765Cobb LA, Fahrenbruch CE, Olsufka M, Copass MK. Changing incidence of out-of-hospital ventricular fibrillation, 1980-2000. JAMA. 2002 Dec 18;288(23):3008-13. doi: 10.1001/jama.288.23.3008.
- Background: PubMed 1728458Niemann JT, Cairns CB, Sharma J, Lewis RJ. Treatment of prolonged ventricular fibrillation. Immediate countershock versus high-dose epinephrine and CPR preceding countershock. Circulation. 1992 Jan;85(1):281-7. doi: 10.1161/01.cir.85.1.281.
- Background: PubMed 12447332Angelos MG, Stoner JD. Cardiopulmonary resuscitation, ventilation, defibrillation: in what order? Ann Emerg Med. 2002 Dec;40(6):571-4. doi: 10.1067/mem.2002.130130. No abstract available.
- Background: PubMed 12636468Valenzuela TD. Priming the pump--can delaying defibrillation improve survival after sudden cardiac death? JAMA. 2003 Mar 19;289(11):1434-6. doi: 10.1001/jama.289.11.1434. No abstract available.
- Background: PubMed 11071670Valenzuela TD, Roe DJ, Nichol G, Clark LL, Spaite DW, Hardman RG. Outcomes of rapid defibrillation by security officers after cardiac arrest in casinos. N Engl J Med. 2000 Oct 26;343(17):1206-9. doi: 10.1056/NEJM200010263431701.
- Background: PubMed 16154680Eftestol T, Losert H, Kramer-Johansen J, Wik L, Sterz F, Steen PA. Independent evaluation of a defibrillation outcome predictor for out-of-hospital cardiac arrested patients. Resuscitation. 2005 Oct;67(1):55-61. doi: 10.1016/j.resuscitation.2005.05.006.
- Background: PubMed 15210599Eftestol T, Wik L, Sunde K, Steen PA. Effects of cardiopulmonary resuscitation on predictors of ventricular fibrillation defibrillation success during out-of-hospital cardiac arrest. Circulation. 2004 Jul 6;110(1):10-5. doi: 10.1161/01.CIR.0000133323.15565.75. Epub 2004 Jun 21.
- 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 12393821Caffrey SL, Willoughby PJ, Pepe PE, Becker LB. Public use of automated external defibrillators. N Engl J Med. 2002 Oct 17;347(16):1242-7. doi: 10.1056/NEJMoa020932.
- 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 15461996Heightman AJ. Eagle Creek report: results of the 2-day consensus retreat on leading controversies in EMS. JEMS. 2004 Sep;29(9):suppl 7-9. No abstract available.
- Background: PubMed 17107744Snyder DE, White RD, Jorgenson DB. Outcome prediction for guidance of initial resuscitation protocol: Shock first or CPR first. Resuscitation. 2007 Jan;72(1):45-51. doi: 10.1016/j.resuscitation.2006.05.018. Epub 2006 Nov 14.
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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.
John P Freese, MD principal investigator
New York City Fire Department
Bradley J Kaufman, MD, MPH study director
New York City Fire Department
Rachael Donohoe, PhD study director
London Ambulance Service
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated external defibrillator (Philips FR2+ AED), SmartCPR and Delayed defibrillation in people with Ventricular Fibrillation and Cardiac Arrest, run by New York City Fire Department at 2 sites in 2 countries.
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 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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.
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?
Survival to Hospital Discharge (time frame: Variable (depends upon interval needed for hospital admission and discharge)). 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 NCT00535106, which also lists 61 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 19 Oct 2009; AzTrials last refreshed its copy on 31 Oct 2026.