Clinical trial NCT00597207: Circulation Improving Resuscitation Care (CIRC)
Official title: A Randomized Controlled Study Comparing Autopulse To Manual CPR In A CPR-First Protocol For Out-Of-Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Cardiopulmonary Resuscitation
Keywords: CPR
mechanical
manual
outcome
survival
quality
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Ullevaal University Hospital
First posted: 2008-01-17
Enrollment: 4231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During resuscitation of out of hospital cardiac arrest patients the use of a mechanical chest compression device Autopulse will improve survival compared to manual compressions.

Detailed description: Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Several studies document sub optimal quality of manual chest compressions and this may influence outcome. However, studies comparing manual and mechanical chest compressions have resulted in conflicted results. The investigators think this may be based on methodology and design issues of the trials as much as not focusing on training and experience in operating a mechanical device clinically. Therefore the investigators will focus on these issues and implement three phases in the study (In field training, Run In phase, and Study phase). The investigators will also focus on early use of mechanical CPR after arrival at patient side and randomization at arrival. In order to achieve this the investigators will follow the Norwegian CPR Guidelines with 3 min CPR before defibrillation and the 3 min algorithm. Quality of CPR will be monitored.

Eligibility criteria: Inclusion Criteria:

* Patents aged 18 years (or local age of consent) or more who suffer non-traumatic arrest of presumed cardiac etiology in an out-of-hospital setting and who do not meet any of the exclusion criteria below.

Exclusion Criteria:

* Traumatic arrest (blunt, penetrating, burns)
* Arrest due to exsanguinations, strangulation, smoke inhalation, drug overdose, electrocution, hanging, drowning.
* Known or clinically apparent pregnancy
* Do Not Attempt to Resuscitate (DNAR) orders
* Apparent patient weight more than 225 kg (500 lbs)
* Wards of the state
* Prisoner
* CPR device other than AutoPulse
* Patients who are reached after 16 minutes after the time of emergency call (911). This exclusion is determined at the time of CRF abstraction, not during treatment of the patient.

  * If patient is unaccompanied, or accompanied by a person or persons unfamiliar with their his-tory, determination of these exclusion criteria will, perforce, be left to the best estimation of the rescue personnel. At no time, should an attempt to determine these criteria be allowed to delay the administration of life-saving treatment.

    * These criteria will be determined in the best estimation of the rescue personnel, or if the AutoPulse signals that the patient is outside the parameters for AutoPulse deployment.

Primary outcomes:
measure: Hospital Discharge
timeFrame: From time of first contact until hospital discharge, up to 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Hillsborough Fire Rescue
state: Florida
city: Houston
country: United States
facility: Houston Fire
state: Texas
city: Menasha
country: United States
facility: Gold Cross EMS
state: Wisconsin
city: Vienna
country: Austria
facility: Vienna EMS
city: Nijmegen
country: Netherlands
facility: Nijmegen EMS
Study officials:
affiliation: Ullevaal University Hospital
name: Lars Wik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Houston Fire
name: David Persse, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olsen JA, Brunborg C, Steinberg M, Persse D, Sterz F, Lozano M Jr, Westfall M, van Grunsven PM, Lerner EB, Wik L. Survival to hospital discharge with biphasic fixed 360 joules versus 200 escalating to 360 joules defibrillation strategies in out-of-hospital cardiac arrest of presumed cardiac etiology. Resuscitation. 2019 Mar;136:112-118. doi: 10.1016/j.resuscitation.2019.01.020. Epub 2019 Jan 29.
citation: Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4.
citation: Steinberg MT, Olsen JA, Brunborg C, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, van Grunsven PM, Travis DT, Lerner EB, Wik L. Minimizing pre-shock chest compression pauses in a cardiopulmonary resuscitation cycle by performing an earlier rhythm analysis. Resuscitation. 2015 Feb;87:33-7. doi: 10.1016/j.resuscitation.2014.11.012. Epub 2014 Nov 21.
citation: Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Malzer R, van Grunsven PM, Travis DT, Whitehead A, Herken UR, Lerner EB. Manual vs. integrated automatic load-distributing band CPR with equal survival after out of hospital cardiac arrest. The randomized CIRC trial. Resuscitation. 2014 Jun;85(6):741-8. doi: 10.1016/j.resuscitation.2014.03.005. Epub 2014 Mar 15.
citation: Lerner EB, Persse D, Souders CM, Sterz F, Malzer R, Lozano M Jr, Westfall M, Brouwer MA, van Grunsven PM, Whitehead A, Olsen JA, Herken UR, Wik L. Design of the Circulation Improving Resuscitation Care (CIRC) Trial: a new state of the art design for out-of-hospital cardiac arrest research. Resuscitation. 2011 Mar;82(3):294-9. doi: 10.1016/j.resuscitation.2010.11.013. Epub 2010 Dec 31.