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Clinical Trials/NCT00539539
NCT00539539
Completed
Phase 2

Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites

University of Washington3 sites in 2 countries1,586 target enrollmentFebruary 2007
ConditionsHeart Arrest

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Arrest
Sponsor
University of Washington
Enrollment
1586
Locations
3
Primary Endpoint
Rate of ROSC During the Prehospital Resuscitation
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to evaluate whether or not real-time feedback on CPR process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.

Detailed Description

A subset of emergency medical services (EMS) agencies that are participating in the Resuscitation Outcomes Consortium (ROC) are adopting new monitor/defibrillators that are capable of monitoring CPR process during attempted resuscitation of patients in cardiac arrest, as well as providing automated real-time feedback about this process to EMS providers so as to improve compliance with recommended guidelines for CPR. Monitoring of CPR process during attempted resuscitation is an important step towards reducing the potential for poorly-performed CPR to modify the effect of the study interventions upon outcome. Clusters formed of rigs, an individual agency or groups of agencies were randomized to turn feedback on or off. After a fixed period of time, each cluster crossed over to the other arm. An unequal number of subjects were enrolled during each period.

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
September 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susanne May

Professor

University of Washington

Eligibility Criteria

Inclusion Criteria

  • all individuals who experience cardiac arrest outside the hospital,
  • are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized EMS personnel.

Exclusion Criteria

  • Use of a mechanical CPR device

Outcomes

Primary Outcomes

Rate of ROSC During the Prehospital Resuscitation

Time Frame: Prehospital resuscitation

Return of spontaneous circulation (ROSC)

Secondary Outcomes

  • Compression Rate(Up to 10 minutes of CPR)
  • Percentage of Compressions With an Incomplete Release(Up to 10 minutes of CPR)
  • Pulses Present at ED Arrival.(Resuscitation)
  • Ventilation Rate(Up to 10 minutes of CPR)
  • Survival to Hospital Discharge(Length of Hospitalization)
  • CPR Fraction(Up to 10 minutes of CPR)
  • Compression Depth(Up to 10 minutes of CPR)

Study Sites (3)

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