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Circulation Improving Resuscitation Care (CIRC) (CIRC)

Primary Purpose

Cardiac Arrest, Cardiopulmonary Resuscitation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AutoPulse
Manual
Sponsored by
Zoll Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring CPR, mechanical, manual, outcome, survival, quality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hillsborough Fire Rescue
  • Houston Fire
  • Gold Cross EMS
  • Vienna EMS
  • Nijmegen EMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

Mechanical CPR with AutoPulse

Manual CPR

Outcomes

Primary Outcome Measures

Hospital Discharge
Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2008
Last Updated
June 25, 2018
Sponsor
Zoll Medical Corporation
Collaborators
Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00597207
Brief Title
Circulation Improving Resuscitation Care (CIRC)
Acronym
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation
Collaborators
Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Cardiopulmonary Resuscitation
Keywords
CPR, mechanical, manual, outcome, survival, quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Mechanical CPR with AutoPulse
Arm Title
2
Arm Type
Other
Arm Description
Manual CPR
Intervention Type
Device
Intervention Name(s)
AutoPulse
Intervention Description
Mechanical device that provides chest compression
Intervention Type
Other
Intervention Name(s)
Manual
Intervention Description
Manual chest compression
Primary Outcome Measure Information:
Title
Hospital Discharge
Description
Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.
Time Frame
From time of first contact until hospital discharge, up to 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Wik, MD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Persse, MD
Organizational Affiliation
Houston Fire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillsborough Fire Rescue
City
Tampa
State/Province
Florida
ZIP/Postal Code
33610
Country
United States
Facility Name
Houston Fire
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Gold Cross EMS
City
Menasha
State/Province
Wisconsin
ZIP/Postal Code
54952
Country
United States
Facility Name
Vienna EMS
City
Vienna
Country
Austria
Facility Name
Nijmegen EMS
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
30708074
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.
Results Reference
derived
PubMed Identifier
27155547
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.
Results Reference
derived
PubMed Identifier
25461493
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.
Results Reference
derived
PubMed Identifier
24642406
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. Erratum In: Resuscitation. 2014 Sep;85(9):1306.
Results Reference
derived
PubMed Identifier
21196070
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.
Results Reference
derived

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Circulation Improving Resuscitation Care (CIRC)

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