Survival Study After Out-of-hospital Cardiac Arrest

Out-of-Hospital Cardiac Arrest Clinical Trial

— SAMS  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02184468
• Other study ID #: SAMS 242-11
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2014
• Last updated: July 8, 2014
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Karolinska Institutet
• Contact: Leif Svensson
• Phone: +4686161000
• Email: leif.svensson[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and WelfareSweden: Regional Ethical Review Board, GothenburgSweden: Swedish Data Inspection Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
Sweden	Center for Resuscitation Science, Sodersjukhuset	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	Ministry of Health and Social Affairs, Sweden, Swedish Association of Local Authorities and Regions, Swedish Heart Lung Foundation, The Laerdal Foundation for Acute Medicine in Norway

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		30-days after out-of-hospital cardiac arrest (OHCA)	No
Secondary	Time for dispatching of fire fighters and/or police	Data are obtained digitally from the dispatch center.	Up to 1 y after ending recruitement	No
Secondary	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.	Up to 1 y after ending recruitement	No
Secondary	Time for attaching the defibrillator to the patient	Data are collected from protocols sent in on line by first responders.	Up to 1 y after ending recruitement	No
Secondary	Time to first defibrillation	Data collected from the protocol sent in on line by first responders.	Up to 1 y after ending recruitement	No