SmartCPR Trial: An Analysis of a Waveform-Based Automated External Defibrillation (AED) Algorithm on Survival From Out-of-Hospital Ventricular Fibrillation (SmartCPR)
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ClinicalTrials.gov Identifier: NCT00535106 |
Recruitment Status
:
Completed
First Posted
: September 26, 2007
Last Update Posted
: October 19, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ventricular Fibrillation Cardiac Arrest | Device: Automated external defibrillator (Philips FR2+ AED) Device: SmartCPR Other: Delayed defibrillation | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | An International, Randomized, Controlled Prehospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard resusc
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.
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Device: Automated external defibrillator (Philips FR2+ AED)
Patients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts.
Other Name: Philips FR2+ AED
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Experimental: SmartCPR
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.
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Device: SmartCPR
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.
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Active Comparator: Delayed defib
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.
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Other: Delayed defibrillation
In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation.
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- Survival to Hospital Discharge [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- initial treatment includes application of a study AED
- complete initial waveform analysis
- presenting rhythm is ventricular fibrillation
- arrest of cardiac etiology
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535106
United States, New York | |
New York City Fire Department | |
New York, New York, United States, 11201 | |
United Kingdom | |
London Ambulance Service | |
London, England, United Kingdom |
Principal Investigator: | John P Freese, MD | New York City Fire Department | |
Study Director: | Bradley J Kaufman, MD, MPH | New York City Fire Department | |
Study Director: | Rachael Donohoe, PhD | London Ambulance Service | |
Study Director: | Dawn Jorgenson, PhD | Philips Medical Systems |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | John Freese, M.D., New York City Fire Department |
ClinicalTrials.gov Identifier: | NCT00535106 History of Changes |
Other Study ID Numbers: |
H05290 |
First Posted: | September 26, 2007 Key Record Dates |
Last Update Posted: | October 19, 2009 |
Last Verified: | October 2009 |
Keywords provided by New York City Fire Department:
Ventricular fibrillation Cardiac arrest Automated external defibrillator |
AED Waveform based algorithms VF waveform analysis |
Additional relevant MeSH terms:
Heart Arrest Ventricular Fibrillation Heart Diseases |
Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes |