Circulation Improving Resuscitation Care (CIRC)

This study has been completed.
Sponsor:
Collaborator:
Ullevaal University Hospital
Information provided by (Responsible Party):
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT00597207
First received: January 8, 2008
Last updated: March 8, 2014
Last verified: March 2014

January 8, 2008
March 8, 2014
January 2008
February 2011   (final data collection date for primary outcome measure)
Hospital Discharge [ Time Frame: At Hospital Discharge ] [ Designated as safety issue: No ]
Hospital discharge [ Time Frame: Dispatched from hospital ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00597207 on ClinicalTrials.gov Archive Site
  • Neurology [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Sustained ROSC, Survival to 24 Hours, Hospital Discharge With a MRS ≤ 3, Process Outcomes: Number of Shocks, Duration of Pulselessness From 911 Call to ROSC, Hands-on Interval or Other Measures of CPR Quality [ Time Frame: during the case ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Circulation Improving Resuscitation Care (CIRC)
A Randomized Controlled Study Comparing Autopulse To Manual CPR In A CPR-First Protocol For Out-Of-Hospital Cardiac Arrest

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Cardiac Arrest
  • Cardiopulmonary Resuscitation
  • Device: Autopulse
    Mechanical chest compression
    Other Name: AutoPulse
  • Device: AutoPulse
    Mechanical device that provides chest compression
    Other Name: Autopulse
  • Other: Manual
    Manual chest compression
    Other Name: Manual
  • Experimental: 1
    Mechanical CPR with AutoPulse
    Interventions:
    • Device: Autopulse
    • Device: AutoPulse
  • 2
    Manual CPR
    Intervention: Other: Manual
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4231
December 2013
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Netherlands
 
NCT00597207
Zoll-0100
Yes
Zoll Medical Corporation
Zoll Medical Corporation
Ullevaal University Hospital
Principal Investigator: Lars Wik, MD Ullevaal University Hospital
Principal Investigator: David Persse, MD Houston Fire
Zoll Medical Corporation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP