NCT01789554

Brief Summary

Death from cardiac disease is one of the most common causes of death in the western world. The majority of these deaths takes place outside hospital as sudden cardiac death. However, with immediate (within minutes) actions such as cardiopulmonary resuscitation (CPR) and defibrillation many lives would be saved. CPR is a key factor to increase survival from Out of Hospital Cardiac Arrest (OHCA). CPR buys time by supporting the brain with some circulation in waiting for a defibrillator that can restart the heart. In Sweden about 2,5 million people are trained in CPR. However, only about half of all OHCA victims will get CPR in waiting for ambulance arrival. The aims of the Response to Urgent Mobile message for Bystander Activation (RUMBA) trial is to try a new way of logistics to increase bystander CPR by recruiting lay volunteers to nearby OHCAs via their mobile phones. Hypothesis: By dispatching lay volunteers to nearby OHCAs with mobile phone technology bystander CPR may increase from 50% to 62,5 %

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

February 6, 2013

Last Update Submit

September 10, 2014

Conditions

Keywords

Out of hospital cardiac arrestCardiopulmonary resuscitationBystander CPRMobile phone positioning system

Outcome Measures

Primary Outcomes (1)

  • Bystander CPR by trained bystander before arrival of ambulance, firefighters or police

    Bystander CPR is defined as CPR by trained laymen in Out of hospital Cardiac Arrest patients before arrival of ambulance, firefighters or police and this only in OHCA patients were care is continued by ambulance crew. CPR in cases showing obvious signs of death are excluded. Telephone assisted CPR by untrained laymen is not accounted for as bystander CPR.

    Within 1 hour from randomization

Secondary Outcomes (7)

  • OHCAs were lay volunteers dispatched by the mobile positioning system arriving prior to ambulance

    Within 1 hour from randomization

  • Time of bystander CPR before arrival of ambulance, firefighters or police

    Within 1 hour from randomization

  • Rhythm on first ECG

    Within 1 hour from randomization

  • Return of spontaneous circulation (ROSC)

    Within 3 hours from randomization

  • Admitted alive

    24 hours after hospital admission

  • +2 more secondary outcomes

Study Arms (2)

MLS dispatch for bystander CPR

EXPERIMENTAL

When an alarm call of a suspected OHCA suspected is received by the EMS dispatch operator a Mobile positioning system (MPS) is activated. The MPS uses the mobile phone network to geographically locate all lay volunteers connected to a tailored mobile phone service called mobile life saver (MLS). The MPS then locates all lay volunteers within a pre defined radius from the suspected OHACA an alerts them with a computer generated voice call and an sms containing data about were about were the suspected OHCA is located. A map is also sent in order to make route finding easy.

Other: MLS dispatch for bystander CPR

NO MLS dispatch for bystander CPR

NO INTERVENTION

No activation of mobile positioning system to locate and recruit lay responders to nearby OHCAs

Interventions

MLS dispatch for bystander CPR

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All suspected OHCAs in Stockholm County
  • All EMS treated out of hospital cardiac arrest in Stockholm County were the mobile positioning system is triggered

You may not qualify if:

  • Traumatic OHCA
  • Children under 8 years of age
  • Suicide
  • Intoxications
  • Obvious signs of death
  • Do not resuscitate orders (DNR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology Södersjukhuset

Stockholm, Stockholm County, 11883, Sweden

Location

Related Publications (1)

  • Ringh M, Rosenqvist M, Hollenberg J, Jonsson M, Fredman D, Nordberg P, Jarnbert-Pettersson H, Hasselqvist-Ax I, Riva G, Svensson L. Mobile-phone dispatch of laypersons for CPR in out-of-hospital cardiac arrest. N Engl J Med. 2015 Jun 11;372(24):2316-25. doi: 10.1056/NEJMoa1406038.

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestDeath, Sudden, CardiacHeart DiseasesVentricular Fibrillation

Condition Hierarchy (Ancestors)

Heart ArrestCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, Cardiac

Study Officials

  • Leif Svensson, Professor

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 12, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations