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
  Purpose

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.


Condition Intervention
Cardiac Arrest
Cardiopulmonary Resuscitation
Device: Autopulse
Device: AutoPulse
Other: Manual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Comparing Autopulse To Manual CPR In A CPR-First Protocol For Out-Of-Hospital Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • Hospital Discharge [ Time Frame: At Hospital Discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4231
Study Start Date: January 2008
Study Completion Date: December 2013
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mechanical CPR with AutoPulse
Device: Autopulse
Mechanical chest compression
Other Name: AutoPulse
Device: AutoPulse
Mechanical device that provides chest compression
Other Name: Autopulse
2
Manual CPR
Other: Manual
Manual chest compression
Other Name: Manual

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597207

Locations
United States, Florida
Hillsborough Fire Rescue
Hillsborough, Florida, United States, 33610
United States, Texas
Houston Fire
Houston, Texas, United States, 77002
United States, Wisconsin
Gold Cross EMS
Menasha, Wisconsin, United States, 54952
Austria
Vienna EMS
Vienna, Austria
Netherlands
Nijmegen EMS
Nijmegen, Netherlands
Sponsors and Collaborators
Zoll Medical Corporation
Ullevaal University Hospital
Investigators
Principal Investigator: Lars Wik, MD Ullevaal University Hospital
Principal Investigator: David Persse, MD Houston Fire
  More Information

No publications provided by Zoll Medical Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT00597207     History of Changes
Other Study ID Numbers: Zoll-0100
Study First Received: January 8, 2008
Results First Received: March 8, 2014
Last Updated: March 8, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Zoll Medical Corporation:
CPR
mechanical
manual
outcome
survival
quality

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014