Clinical trial NCT00535106: SmartCPR Trial: An Analysis of a Waveform-Based Automated External Defibrillation (AED) Algorithm on Survival From Out-of-Hospital Ventricular Fibrillation
Official title: An International, Randomized, Controlled Prehospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Fibrillation
Cardiac Arrest
Keywords: Ventricular fibrillation
Cardiac arrest
Automated external defibrillator
AED
Waveform based algorithms
VF waveform analysis
Lead sponsor: New York City Fire Department
Sponsor class: OTHER_GOV
Collaborators: name: Philips Medical Systems
name: London Ambulance Service
First posted: 2007-09-26
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Survival to Hospital Discharge
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
Secondary outcomes:
measure: Survival to hospital admission
timeFrame: within hours from the time of arrest
measure: Return of spontaneous circulation (ROSC) in prehospital setting
timeFrame: Variable (depends on EMS contact time)
measure: Neurological status among survivors
timeFrame: Variable (measured at hospital discharge)
measure: Survival (defined as ROSC, survival to hospital admission, and survival to hospital discharge) as compared to a "delayed defibrillation" cohort in NYC
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Impact of CPR interval on VF waveform characteristics
timeFrame: Immediately after CPR interval
measure: Utility of AED algorithm and VF characteristics among EMS-witnessed arrests
timeFrame: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge)
measure: Utility of this AED technology and VF characteristics among pediatric patients
timeFrame: Variable (some immediate data, some depends upon interval needed for hospital admission and discharge)
measure: Impact of bystander CPR on VF waveform characteristics
timeFrame: Immediate (taken from data during arrest)
measure: Comparison of EMS response times to VF waveform characteristics
timeFrame: Immediate (data obtained during EMS response and arrest period)
measure: Frequency of unmanageable airways in out-of-hospital cardiac arrest patients
timeFrame: Immediate (measured at the time of arrest)
measure: Impact of patient race upon the provision of bystander CPR, VF waveform characteristics, and survival
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Relationship between presenting and interval waveform capnography readings and survival
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Frequency of organ donation among out-of-hospital cardiac arrest patients transported to the hospital who do not survive to hospital discharge
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Waveform characteristics among patients presenting in secondary VF (initial presenting rhythm asystole or pulseless electrical activity)
timeFrame: Immediate (derived from data collected during the arrest)
measure: Description of and outcomes of patients for whom intraosseous access is utilized during the cardiac arrest
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Utstein comparison of two cities (London and New York)
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Impact of bystander CPR on survival as a function of response time
timeFrame: Variable (depends upon interval needed for hospital admission and discharge)
measure: Association between ambient small particle (PM2.5) pollution and cardiac arrest indicence in New York City
timeFrame: To be determined by modelling
Other outcomes:
Locations:
city: New York
country: United States
facility: New York City Fire Department
state: New York
city: London
country: United Kingdom
facility: London Ambulance Service
state: England
Study officials:
affiliation: New York City Fire Department
name: John P Freese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York City Fire Department
name: Bradley J Kaufman, MD, MPH
role: STUDY_DIRECTOR
affiliation: London Ambulance Service
name: Rachael Donohoe, PhD
role: STUDY_DIRECTOR
affiliation: Philips Medical Systems
name: Dawn Jorgenson, PhD
role: STUDY_DIRECTOR
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