Survival Study After Out-of-hospital Cardiac Arrest (SAMS)

July 8, 2014 updated by: Leif Svensson, Karolinska Institutet

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-11883
        • Recruiting
        • Center for Resuscitation Science, Sodersjukhuset
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All cases where the dispatcher suspects cardiac arrest, i.e. unconscious person with abnormal or no breathing

Exclusion Criteria:

  • Children < 8 y
  • Obviously deceased persons according to regulations in EMS protocols

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Dual dispatch
Simultaneously dispatching of EMS, firefighters and/or police in OHCA
Other: Simultaneously dispatch of firefighters and/or police in case of OHCA
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Survival
Time Frame: 30-days after out-of-hospital cardiac arrest (OHCA)
30-days after out-of-hospital cardiac arrest (OHCA)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time for dispatching of fire fighters and/or police
Time Frame: Up to 1 y after ending recruitement
Data are obtained digitally from the dispatch center.
Up to 1 y after ending recruitement
Time for arrival to the patient
Time Frame: Up to 1 y after ending recruitement
Data are collected both digitally from the dispatch center and from protocols sent in on line by first responders.
Up to 1 y after ending recruitement
Time for attaching the defibrillator to the patient
Time Frame: Up to 1 y after ending recruitement
Data are collected from protocols sent in on line by first responders.
Up to 1 y after ending recruitement
Time to first defibrillation
Time Frame: Up to 1 y after ending recruitement
Data collected from the protocol sent in on line by first responders.
Up to 1 y after ending recruitement

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swedish Heart Lung Foundation
Ministry of Health and Social Affairs, Sweden
Swedish Association of Local Authorities and Regions
The Laerdal Foundation for Acute Medicine in Norway

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leif Svensson, MD, PhD, Center for Resuscitation Science, Karolinska Institutet, Stockholm, Sweden

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAMS 242-11

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