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

NCT00535106 | Completed DMC

• 1 other identifier: H05290
• Study Type: interventional
• Target: 900
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ventricular Fibrillation; Cardiac Arrest

Keywords

Ventricular fibrillation; Cardiac arrest; Automated external defibrillator; AED; Waveform based algorithms; VF waveform analysis

Outcome Measures

Primary Outcomes (1)

• Survival to Hospital Discharge

  Variable (depends upon interval needed for hospital admission and discharge)

Secondary Outcomes (18)

• Survival to hospital admission

  within hours from the time of arrest

• Return of spontaneous circulation (ROSC) in prehospital setting

  Variable (depends on EMS contact time)

• Neurological status among survivors

  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

  Variable (depends upon interval needed for hospital admission and discharge)

• Impact of CPR interval on VF waveform characteristics

  Immediately after CPR interval

Study Arms (3)

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.

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.

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.

Other: Delayed defibrillation

Interventions

Automated external defibrillator (Philips FR2+ AED) DEVICE

Patients in this arm will be provided with immediate defibrillatory shock coupled with otherwise standard resuscitative efforts.

Also known as: Philips FR2+ AED

Standard resusc

SmartCPR DEVICE

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.

SmartCPR

Delayed defibrillation OTHER

In New York City only, all patients not initially treated by study personnel will receive other regional standard for resuscitation - delayed defibrillation.

Delayed defib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• initial treatment includes application of a study AED
• complete initial waveform analysis
• presenting rhythm is ventricular fibrillation
• arrest of cardiac etiology

You may not qualify if:

• 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

Sponsors & Collaborators

• New York City Fire Department: lead
• Philips Medical Systems: collaborator
• London Ambulance Service: collaborator

Study Sites (2)

New York City Fire Department

New York, New York, 11201, United States

Location

London Ambulance Service

London, England, United Kingdom

Location

Related Publications (61)

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• Sherman LD. The frequency ratio: an improved method to estimate ventricular fibrillation duration based on Fourier analysis of the waveform. Resuscitation. 2006 Jun;69(3):479-86. doi: 10.1016/j.resuscitation.2005.09.024. Epub 2006 Mar 23.

  PMID: 16563594 BACKGROUND

• Callaway CW, Menegazzi JJ. Waveform analysis of ventricular fibrillation to predict defibrillation. Curr Opin Crit Care. 2005 Jun;11(3):192-9. doi: 10.1097/01.ccx.0000161725.71211.42.

  PMID: 15928465 BACKGROUND

• Pepe PE, Fowler RL, Roppolo LP, Wigginton JG. Clinical review: Reappraising the concept of immediate defibrillatory attempts for out-of-hospital ventricular fibrillation. Crit Care. 2004 Feb;8(1):41-5. doi: 10.1186/cc2379. Epub 2003 Sep 29.

  PMID: 14975044 BACKGROUND

• Menegazzi JJ, Callaway CW, Sherman LD, Hostler DP, Wang HE, Fertig KC, Logue ES. Ventricular fibrillation scaling exponent can guide timing of defibrillation and other therapies. Circulation. 2004 Feb 24;109(7):926-31. doi: 10.1161/01.CIR.0000112606.41127.D2. Epub 2004 Feb 2.

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  PMID: 14666442 BACKGROUND

• Lightfoot CB, Nremt-P, Callaway CW, Hsieh M, Fertig KC, Sherman LD, Menegazzi JJ. Dynamic nature of electrocardiographic waveform predicts rescue shock outcome in porcine ventricular fibrillation. Ann Emerg Med. 2003 Aug;42(2):230-41. doi: 10.1067/mem.2003.264.

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  PMID: 23979627 DERIVED

MeSH Terms

Conditions

Ventricular Fibrillation; Heart Arrest

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• John P Freese, MD

  New York City Fire Department

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: May 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 19, 2009

Record last verified: 2009-10

Locations

GB (1); US (1)