Circulation Improving Resuscitation Care (CIRC)

NCT ID: NCT00597207

Last Updated: 2018-07-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest Cardiopulmonary Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Mechanical CPR with AutoPulse

Group Type EXPERIMENTAL

AutoPulse

Intervention Type DEVICE

Mechanical device that provides chest compression

2

Manual CPR

Group Type OTHER

Manual

Intervention Type OTHER

Manual chest compression

Interventions

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AutoPulse

Mechanical device that provides chest compression

Intervention Type DEVICE

Manual

Manual chest compression

Intervention Type OTHER

Eligibility Criteria

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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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Wik, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

David Persse, MD

Role: PRINCIPAL_INVESTIGATOR

Houston Fire

Locations

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Hillsborough Fire Rescue

Tampa, Florida, United States

Site Status

Houston Fire

Houston, Texas, United States

Site Status

Gold Cross EMS

Menasha, Wisconsin, United States

Site Status

Vienna EMS

Vienna, , Austria

Site Status

Nijmegen EMS

Nijmegen, , Netherlands

Site Status

Countries

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United States Austria Netherlands

References

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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.

Reference Type DERIVED
PMID: 30708074 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27155547 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25461493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24642406 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21196070 (View on PubMed)

Other Identifiers

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Zoll-0100

Identifier Type: -

Identifier Source: org_study_id

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