Circulation Improving Resuscitation Care (CIRC) (CIRC)

June 25, 2018 updated by: Zoll Medical Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Vienna EMS
  • Netherlands
      • Nijmegen, Netherlands
        • Nijmegen EMS
  • United States
    • Florida
      • Tampa, Florida, United States, 33610
        • Hillsborough Fire Rescue
    • Texas
      • Houston, Texas, United States, 77002
        • Houston Fire
    • Wisconsin
      • Menasha, Wisconsin, United States, 54952
        • Gold Cross EMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Mechanical CPR with AutoPulse
Device: AutoPulse
Mechanical device that provides chest compression
Other: 2
Manual CPR
Other: Manual
Manual chest compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Discharge
Time Frame: From time of first contact until hospital discharge, up to 90 days.
Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.
From time of first contact until hospital discharge, up to 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zoll Medical Corporation

Collaborators

Ullevaal University Hospital

Investigators

  • Principal Investigator: Lars Wik, MD, Ullevaal University Hospital
  • Principal Investigator: David Persse, MD, Houston Fire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zoll-0100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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