Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

SmartCPR Trial: An Analysis of a Waveform-Based Automated External Defibrillation (AED) Algorithm on Survival From Out-of-Hospital Ventricular Fibrillation

This study has been completed.
Sponsor:
Collaborators:
Philips Medical Systems
London Ambulance Service
Information provided by:
New York City Fire Department
ClinicalTrials.gov Identifier:
NCT00535106
First received: September 25, 2007
Last updated: October 18, 2009
Last verified: October 2009
  Purpose

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 Intervention
Ventricular Fibrillation
Cardiac Arrest
Device: Automated external defibrillator (Philips FR2+ AED)
Device: SmartCPR
Other: Delayed defibrillation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by New York City Fire Department:

Primary Outcome Measures:
  • Survival to Hospital Discharge [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival to hospital admission [ Time Frame: within hours from the time of arrest ] [ Designated as safety issue: No ]
  • Return of spontaneous circulation (ROSC) in prehospital setting [ Time Frame: Variable (depends on EMS contact time) ] [ Designated as safety issue: No ]
  • Neurological status among survivors [ Time Frame: Variable (measured at hospital discharge) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Impact of CPR interval on VF waveform characteristics [ Time Frame: Immediately after CPR interval ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Impact of bystander CPR on VF waveform characteristics [ Time Frame: Immediate (taken from data during arrest) ] [ Designated as safety issue: No ]
  • Comparison of EMS response times to VF waveform characteristics [ Time Frame: Immediate (data obtained during EMS response and arrest period) ] [ Designated as safety issue: No ]
  • Frequency of unmanageable airways in out-of-hospital cardiac arrest patients [ Time Frame: Immediate (measured at the time of arrest) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Relationship between presenting and interval waveform capnography readings and survival [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Utstein comparison of two cities (London and New York) [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
  • Impact of bystander CPR on survival as a function of response time [ Time Frame: Variable (depends upon interval needed for hospital admission and discharge) ] [ Designated as safety issue: No ]
  • Association between ambient small particle (PM2.5) pollution and cardiac arrest indicence in New York City [ Time Frame: To be determined by modelling ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: May 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:

Additional 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
Study First Received: September 25, 2007
Last Updated: October 18, 2009
Health Authority: United States: Federal Government

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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014