Clinical trial NCT00539539: Automated Real-time Feedback on CPR Study
Official title: Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Arrest
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: The Institute of Circulatory and Respiratory Health (ICRH)
name: Defence Research and Development Canada
First posted: 2007-10-04
Enrollment: 1586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of ROSC During the Prehospital Resuscitation
timeFrame: Prehospital resuscitation
Secondary outcomes:
measure: Pulses Present at ED Arrival.
timeFrame: Resuscitation
measure: Survival to Hospital Discharge
timeFrame: Length of Hospitalization
measure: CPR Fraction
timeFrame: Up to 10 minutes of CPR
measure: Compression Depth
timeFrame: Up to 10 minutes of CPR
measure: Compression Rate
timeFrame: Up to 10 minutes of CPR
measure: Percentage of Compressions With an Incomplete Release
timeFrame: Up to 10 minutes of CPR
measure: Ventilation Rate
timeFrame: Up to 10 minutes of CPR
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Thunder Bay
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: University of Washington
name: Susanne May, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Judy Powell, BSN
role: STUDY_DIRECTOR
References:
citation: Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.