Cardiac ArrestCIRCNCT00597207
Circulation Improving Resuscitation Care (CIRC)
A study testing AutoPulse and Manual in people with Cardiac Arrest and Cardiopulmonary Resuscitation, run by Zoll Medical Corporation at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- AutoPulse and Manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,231 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Houston Fire
Houston, Texas, 77002
Gold Cross EMS
Menasha, Wisconsin, 54952
Hillsborough Fire Rescue
Tampa, Florida, 33610
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation
- Being tested
- AutoPulse, Manual
- Keywords
- CPR, mechanical, manual, outcome, survival, quality
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoPulseDevice
Mechanical device that provides chest compression
ManualOther
Manual chest compression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mechanical CPR with AutoPulse Receives: Device: AutoPulse |
| 2 | Other | Manual CPR Receives: Other: Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Discharge
Whether a subject was discharged alive from the hospital or alternatively died prior to discharge.
Measured: From time of first contact until hospital discharge, up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ullevaal University Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Wik, MD, Principal investigator, Ullevaal University HospitalDavid Persse, MD, Principal investigator, Houston Fire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597207
- Sponsor's protocol ID
- Zoll-0100
- Acronym
- CIRC
- Status last verified
- Jun 2018
- First submitted
- 8 Jan 2008
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30708074Wik 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.
PubMed 27155547Steinberg 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.
PubMed 25461493Wik 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.
PubMed 24642406Lerner 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.
PubMed 21196070
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing Autopulse To Manual CPR In A CPR-First Protocol For Out-Of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00597207
- Acronym / sponsor ID
- CIRC / Zoll-0100
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation
- Keywords
- CPR, mechanical, manual, outcome, survival, quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,231 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Ullevaal University Hospital
- Study start
- Jan 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 14 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: AutoPulseMechanical CPR with AutoPulse |
| 2 | Other | Other: ManualManual CPR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutoPulseMechanical device that provides chest compression | Device | 1 |
| ManualManual chest compression | Other | 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30708074Olsen 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.
- Derived from this study: PubMed 27155547Wik 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.
- Derived from this study: PubMed 25461493Steinberg 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.
- Derived from this study: PubMed 24642406Wik 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.
- Derived from this study: PubMed 21196070Lerner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Wik, MD principal investigator
Ullevaal University Hospital
David Persse, MD principal investigator
Houston Fire
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoPulse and Manual in people with Cardiac Arrest and Cardiopulmonary Resuscitation, run by Zoll Medical Corporation at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Discharge (time frame: From time of first contact until hospital discharge, up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00597207, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.