title: Design of the Circulation Improving Resuscitation Care (CIRC) Trial: a new state of the art design for out-of-hospital cardiac arrest research.
abstract: OBJECTIVE
  Mechanical chest compression devices, such as the AutoPulse(®), have been developed to overcome problems associated with manual CPR (M-CPR). Animal and human studies have shown that AutoPulse CPR improves hemodynamic parameters over M-CPR. However, human studies conducted in the prehospital setting have conflicting results as to the AutoPulse's efficacy in improving survival. The Circulation Improving Resuscitation Care (CIRC) Trial is designed to evaluate the effectiveness of integrated AutoPulse-CPR (iA-CPR) (i.e., M-CPR followed by AutoPulse(®)-CPR) in a randomized controlled trial that addresses methodological issues that may have influenced the results of previous studies.
  
  
  METHODS
  This paper describes the methodology of the CIRC trial.
  
  
  RESULTS
  Unlike previous trials the CIRC trial studies iA-CPR where emphasis is placed on reducing "hands-off" time. The trial has six unique features: (1) training of all EMS providers in a standardized deployment strategy that reduces hands-off time and continuous monitoring for protocol compliance. (2) A pre-trial simulation study of provider compliance with the trial protocol. (3) Three distinct study phases (in-field training, run-in, and statistical inclusion) to minimize the Hawthorne effect and other biases. (4) Monitoring of the CPR process using either transthoracic impedance or accelerometer data. (5) Randomization at the subject level after the decision to resuscitate is made to reduce selection bias. (6) Use of the Group Sequential Double Triangular Test with sufficient power to determine superiority, inferiority, or equivalence.
  
  
  CONCLUSIONS
  This unique, large, multicenter study comparing the effectiveness of iA-CPR to M-CPR will contribute to the science of the treatment of out-of-hospital cardiac arrest as well as to the design of future trials.
authors.affiliation: Department of Emergency Medicine, Medical College of Wisconsin, 9200 W Wisconsin Ave, Milwaukee, WI 53226, United States. eblerner@mcw.edu
authors.forename: E Brooke
authors.initials: EB
authors.lastname: Lerner
authors.forename: David
authors.initials: D
authors.lastname: Persse
authors.forename: Chris M
authors.initials: CM
authors.lastname: Souders
authors.forename: Fritz
authors.initials: F
authors.lastname: Sterz
authors.forename: Reinhard
authors.initials: R
authors.lastname: Malzer
authors.forename: Michael
authors.initials: M
authors.lastname: Lozano
authors.forename: Mark
authors.initials: M
authors.lastname: Westfall
authors.forename: Marc A
authors.initials: MA
authors.lastname: Brouwer
authors.forename: Pierre M
authors.initials: PM
authors.lastname: van Grunsven
authors.forename: Anne
authors.initials: A
authors.lastname: Whitehead
authors.forename: Jan-Aage
authors.initials: JA
authors.lastname: Olsen
authors.forename: Ulrich R
authors.initials: UR
authors.lastname: Herken
authors.forename: Lars
authors.initials: L
authors.lastname: Wik
mesh_terms: D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation / Q000379:methods*; D026690:Ethics, Clinical; D006801:Humans; D058687:Out-of-Hospital Cardiac Arrest / Q000401:mortality / Q000628:therapy*; D018579:Patient Selection; D012107:Research Design; D016896:Treatment Outcome