Out-of-Hospital Cardiac ArrestSAMSNCT02184468
Survival Study After Out-of-hospital Cardiac Arrest
A study testing Simultaneously dispatch of firefighters and/or police in case of OHCA in people with Out-of-Hospital Cardiac Arrest, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary resuscitation (CPR) and defibrillation, thus increasing survival. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- Simultaneously dispatch of firefighters and/or police in case of OHCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All cases where the dispatcher suspects cardiac arrest, i.e. unconscious person with abnormal or no breathing
Who cannot join
- Children < 8 y
- Obviously deceased persons according to regulations in EMS protocols
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Center for Resuscitation Science, Sodersjukhuset
Stockholm, SE-11883
Leif Svensson, MD, PhD, +4686161000, leif.svensson@ki.se
Johan Herlitz, MD, PhD, +46334354000, johan.herlitz@gu.se
About this study
Official title: Dual Dispatch of EMS, Fire Fighters and/or Police in Out-of-hospital Cardiac Arrest Implemented in Nine Counties in Sweden - Can More Lives be Saved by Using This Method?
The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary resuscitation (CPR) and defibrillation, thus increasing survival.
Read the detailed description
Hypothesis If simultaneous dispatch of ambulance (EMS), firefighters and/or police is being initiated when an OHCA occurs, then the two latter units will be first at scene, before the ambulance crew, in ≥30% of the cases. We anticipate therefore that overall 30-days survival will increase on a national level from 9% to 12%.
Method During the period 110901 to 141231 all OHCA cases will be analyzed were the emergency medical communication centre (EMCC) has dispatched ambulance, firefighters and/or the police. Participating in the Saving More Lives in Sweden (SAMS) project are the following counties: Stockholm, Sodermanland, Jonkoping, Vastra Gotaland (VG Region), Halland, Dalarna, Jamtland, Kalmar and Uppsala. Data is collected by the units being dispatched and thereafter sent on line to a database managed by Registercentrum in Gothenburg (http://www.registercentrum.se/), administrators of the Swedish Cardiac Arrest Register.
Parameters obtained are:
- Time for dispatch of fire fighters and/or police (recorded digitally).
- Time for arrival to the patient.
- Verification if cardiac arrest or not.
- CPR performed by fire fighters or police before arrival of EMS.
- Automated External Defibrillator (AED) connected to the patient.
- If yes, was the first recorded rhythm shockable, i.e. ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT).
- Time to defibrillation.
Survival data during from the Swedish Cardiac Arrest Register (SCAR) will be obtained during the same time period from nine comparable Swedish regions not participating in the SAMS study.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- Simultaneously dispatch of firefighters and/or police in case of OHCA
- Keywords
- Cardiac Arrest, Out-of-Hospital Cardiac Arrest, Firefighters, Police, Defibrillators, Survival
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneously dispatch of firefighters and/or police in case of OHCAOther
In case of OHCA, firefighters and/or police trained in CPR and equipped with AEDs will be dispatched in parallel with EMS in nine counties in Sweden.
| Study group | Role | What they receive |
|---|---|---|
| Dual dispatch | Other | Simultaneously dispatching of EMS, firefighters and/or police in OHCA Receives: Other: Simultaneously dispatch of firefighters and/or police in case of OHCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 30-days after out-of-hospital cardiac arrest (OHCA)
Secondary outcomes (4)
Time for dispatching of fire fighters and/or police
Data are obtained digitally from the dispatch center.
Measured: Up to 1 y after ending recruitement
Time for arrival to the patient
Data are collected both digitally from the dispatch center and from protocols sent in on line by first responders.
Measured: Up to 1 y after ending recruitement
Time for attaching the defibrillator to the patient
Data are collected from protocols sent in on line by first responders.
Measured: Up to 1 y after ending recruitement
Time to first defibrillation
Data collected from the protocol sent in on line by first responders.
Measured: Up to 1 y after ending recruitement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startSep 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Foundation, Swedish Heart Lung Foundation, Ministry of Health and Social Affairs, Sweden, Swedish Association of Local Authorities and Regions
- Responsible party
- Principal investigator, Leif Svensson, Karolinska Institutet
- Investigators
- Leif Svensson, MD, PhD, Principal investigator, Center for Resuscitation Science, Karolinska Institutet, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184468
- Sponsor's protocol ID
- SAMS 242-11
- Acronym
- SAMS
- Status last verified
- Jul 2014
- First submitted
- 27 Jun 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hasselqvist-Ax I, Nordberg P, Herlitz J, Svensson L, Jonsson M, Lindqvist J, Ringh M, Claesson A, Bjorklund J, Andersson JO, Ericson C, Lindblad P, Engerstrom L, Rosenqvist M, Hollenberg J. Dispatch of Firefighters and Police Officers in Out-of-Hospital Cardiac Arrest: A Nationwide Prospective Cohort Trial Using Propensity Score Analysis. J Am Heart Assoc. 2017 Oct 4;6(10):e005873. doi: 10.1161/JAHA.117.005873.
PubMed 28978527
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Dispatch of EMS, Fire Fighters and/or Police in Out-of-hospital Cardiac Arrest Implemented in Nine Counties in Sweden - Can More Lives be Saved by Using This Method?
- ClinicalTrials.gov ID
- NCT02184468
- Acronym / sponsor ID
- SAMS / SAMS 242-11
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Cardiac Arrest, Out-of-Hospital Cardiac Arrest, Firefighters, Police, Defibrillators, Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Laerdal Foundation, Swedish Heart Lung Foundation, Ministry of Health and Social Affairs, Sweden, Swedish Association of Local Authorities and Regions
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if dual dispatch of ambulance, fire fighters and/or police in out-of-hospital cardiac arrest (OHCA), can reduce the time to cardiopulmonary resuscitation (CPR) and defibrillation, thus increasing survival.
Detailed description
Hypothesis If simultaneous dispatch of ambulance (EMS), firefighters and/or police is being initiated when an OHCA occurs, then the two latter units will be first at scene, before the ambulance crew, in ≥30% of the cases. We anticipate therefore that overall 30-days survival will increase on a national level from 9% to 12%.
Method During the period 110901 to 141231 all OHCA cases will be analyzed were the emergency medical communication centre (EMCC) has dispatched ambulance, firefighters and/or the police. Participating in the Saving More Lives in Sweden (SAMS) project are the following counties: Stockholm, Sodermanland, Jonkoping, Vastra Gotaland (VG Region), Halland, Dalarna, Jamtland, Kalmar and Uppsala. Data is collected by the units being dispatched and thereafter sent on line to a database managed by Registercentrum in Gothenburg (http://www.registercentrum.se/), administrators of the Swedish Cardiac Arrest Register.
Parameters obtained are:
- Time for dispatch of fire fighters and/or police (recorded digitally).
- Time for arrival to the patient.
- Verification if cardiac arrest or not.
- CPR performed by fire fighters or police before arrival of EMS.
- Automated External Defibrillator (AED) connected to the patient.
- If yes, was the first recorded rhythm shockable, i.e. ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT).
- Time to defibrillation.
Survival data during from the Swedish Cardiac Arrest Register (SCAR) will be obtained during the same time period from nine comparable Swedish regions not participating in the SAMS study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual dispatch | Other | Other: Simultaneously dispatch of firefighters and/or police in case of OHCASimultaneously dispatching of EMS, firefighters and/or police in OHCA |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All cases where the dispatcher suspects cardiac arrest, i.e. unconscious person with abnormal or no breathing
Key exclusion criteria (2 listed)
- Children < 8 y
- Obviously deceased persons according to regulations in EMS protocols
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 |
|---|---|---|
| Simultaneously dispatch of firefighters and/or police in case of OHCAIn case of OHCA, firefighters and/or police trained in CPR and equipped with AEDs will be dispatched in parallel with EMS in nine counties in Sweden. | Other | Dual dispatch |
Primary outcome
Survival
Time frame: 30-days after out-of-hospital cardiac arrest (OHCA)
4 secondary outcomes
Time for dispatching of fire fighters and/or police
Time frame: Up to 1 y after ending recruitement
Time for arrival to the patient
Time frame: Up to 1 y after ending recruitement
Time for attaching the defibrillator to the patient
Time frame: Up to 1 y after ending recruitement
Time to first defibrillation
Time frame: Up to 1 y after ending recruitement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Derived from this study: PubMed 28978527Hasselqvist-Ax I, Nordberg P, Herlitz J, Svensson L, Jonsson M, Lindqvist J, Ringh M, Claesson A, Bjorklund J, Andersson JO, Ericson C, Lindblad P, Engerstrom L, Rosenqvist M, Hollenberg J. Dispatch of Firefighters and Police Officers in Out-of-Hospital Cardiac Arrest: A Nationwide Prospective Cohort Trial Using Propensity Score Analysis. J Am Heart Assoc. 2017 Oct 4;6(10):e005873. doi: 10.1161/JAHA.117.005873.
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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.
Leif Svensson, MD, PhD principal investigator
Center for Resuscitation Science, Karolinska Institutet, Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneously dispatch of firefighters and/or police in case of OHCA in people with Out-of-Hospital Cardiac Arrest, run by Karolinska Institutet at 1 site in Sweden.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leif Svensson (+4686161000, leif.svensson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 30-days after out-of-hospital cardiac arrest (OHCA)). 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 NCT02184468, which also lists 1 linked publication.
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 9 Jul 2014.