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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
Sponsor:
Collaborators:
Philips Medical Systems
London Ambulance Service
Information provided by:
New York City Fire Department

Brief 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.

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Cardiac Arrest Device: Automated external defibrillator (Philips FR2+ AED) Device: SmartCPR Other: Delayed defibrillation Not Applicable

  Show Detailed Description

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

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U.S. FDA Resources

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.
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
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.
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.
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.
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.



Primary Outcome Measures :
  1. Survival to Hospital Discharge [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ]

Secondary Outcome Measures :
  1. Survival to hospital admission [ Time Frame: within hours from the time of arrest ]
  2. Return of spontaneous circulation (ROSC) in prehospital setting [ Time Frame: Variable (depends on EMS contact time) ]
  3. Neurological status among survivors [ Time Frame: Variable (measured at hospital discharge) ]
  4. 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) ]
  5. Impact of CPR interval on VF waveform characteristics [ Time Frame: Immediately after CPR interval ]
  6. 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) ]
  7. 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) ]
  8. Impact of bystander CPR on VF waveform characteristics [ Time Frame: Immediate (taken from data during arrest) ]
  9. Comparison of EMS response times to VF waveform characteristics [ Time Frame: Immediate (data obtained during EMS response and arrest period) ]
  10. Frequency of unmanageable airways in out-of-hospital cardiac arrest patients [ Time Frame: Immediate (measured at the time of arrest) ]
  11. 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) ]
  12. Relationship between presenting and interval waveform capnography readings and survival [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ]
  13. 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) ]
  14. 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) ]
  15. 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) ]
  16. Utstein comparison of two cities (London and New York) [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ]
  17. Impact of bystander CPR on survival as a function of response time [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ]
  18. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
New York City Fire Department
Philips Medical Systems
London Ambulance Service
Investigators
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