search
Back to results

The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR (RUMBA)

Primary Purpose

Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MLS dispatch for bystander CPR
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Out-of-Hospital Cardiac Arrest focused on measuring Out of hospital cardiac arrest, Cardiopulmonary resuscitation, Bystander CPR, Mobile phone positioning system

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Cardiology Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MLS dispatch for bystander CPR

NO MLS dispatch for bystander CPR

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

OHCAs were lay volunteers dispatched by the mobile positioning system arriving prior to ambulance
The proportion of mobile phone dispatched lay volunteers arriving prior to ambulance at the scene of the OHCA
Time of bystander CPR before arrival of ambulance, firefighters or police
The time of bystander CPR performed by mobile phone dispatched lay volunteer before arrival of ambulance, firefighters or police
Rhythm on first ECG
Defined as the cardiac rhythm recorded on first ECG. Either Ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) or asystole/pulseless electrical activity If defibrillation = VF/VT
Return of spontaneous circulation (ROSC)
The return of circulation after successful CPR that can be felt by palpable puls or blod pressure that can be measured
Admitted alive
Admitted from Emergency to hospital ward (usually ICU) and alive 24 h after admission
Alive after 1 month Cerebral Performance Categories (CPC) 1-2
Alive after 30 days with CPC score 1-2. Description: The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact." Good cerebral performance: little to no deficit. Moderate cerebral disability: capable of independent activities of daily life Severe cerebral disability: conscious, but dependent on others for daily support Coma or vegetative state Death or brain death
Alive after 1 month CPC 1-2
Alive after 90 days with CPC score 1-2.

Full Information

First Posted
February 6, 2013
Last Updated
September 10, 2014
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT01789554
Brief Title
The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR
Acronym
RUMBA
Official Title
The Response to Urgent Mobile Message for Bystander Activation (RUMBA) Trial - The Use of Mobile Phone Positioning for Dispatch of Bystanders to Out of Hospital Cardiac Arrest.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 %
Detailed Description
Survival from out-of-hospital cardiac arrest (OHCA) is generally low, about 5-10%, with the exception of a few controlled settings (casinos, airports and some cities). The poor prognosis of OHCA is mainly explained by long time intervals between cardiac arrest, cardiopulmonary resuscitation (CPR) and defibrillation. To increase bystander actions and to decrease time to defibrillation substantial resources have been put into CPR educational campaigns and in recent years into the spread of automated external defibrillators (AEDs) in public venues. Still, the vast majority of the public with CPR training will never use their skills in real life. Mobile phone technology offers the possibility to locate single mobile phone users at any given moment. If designated lay responders immediately can be identified and recruited to the scene of nearby suspected OHCAs bystander CPR, CPR quality and finally survival might be increased. Mobile phone positioning and dispatching of lay responders: Tailored mobile phone services that use MPS to locate selected mobile phone users can be developed for different purposes. A computer-based application for mobile phone positioning and dispatch of lay responders is developed for the purpose of this study and is referred to as the Mobile Lifesaver Service (MLS). All participants connected to the MLS are called Mobile Responders (MRs). The MLS acts as an interface between the emergency medical service (EMS) data system and the MPS. The MLS handles the localisation and dispatching of MRs based on the data present in the EMS data system. The location of all incoming calls to all dispatch centres in Sweden is determined automatically. When the dispatcher receives an emergency call from a witness of a suspected OHCA the dispatcher activates the MLS in parallel with standard EMS. When the MLS is activated it uses the MPS to compare the current geographical position of all MRs connected to the MLS with the position of the incoming emergency call of the suspected cardiac arrest. If one or more MRs is present within a radius of 500 m (optional) from the suspected arrest the MRs receives a cardiac arrest alert with a computer generated phone call and a text message (i.e. SMS = short message system) with information about the place of the suspected cardiac arrest. A map for finding the way to the suspected OHCA is also sent. Additional information can, if needed, be sent to the MRs. For further details see "Mobile phone technology identifies and recruits trained citizens to perform CPR on out-of-hospital cardiac arrest victims prior to ambulance arrival." Ringh M, Fredman D, Nordberg P, Stark T, Hollenberg J. Resuscitation. 2011 Dec;82(12):1514-8. Data from earlier non randomized pilot studies in urban Stockholm has shown that CPR was performed by MLS dispatched lifesavers prior to ambulance, firefighters and police in about 20 % of all cases of true OHCAs. The hypothesis is that bystander CPR in Stockholm County can be increased from 50 % to 62,5% if the MLS is used. An estimated number of 6000 MR needed is based on earlier pilot studies. The current proportion of bystander CPR is derived from OHCA registry data but is uncertain. A safety and efficacy analyze will be made at approximately 200 true OHCA cases. A ethical and safety board and log for adverse events will be set up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac, Heart Diseases, Ventricular Fibrillation
Keywords
Out of hospital cardiac arrest, Cardiopulmonary resuscitation, Bystander CPR, Mobile phone positioning system

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MLS dispatch for bystander CPR
Arm Type
Experimental
Arm Description
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.
Arm Title
NO MLS dispatch for bystander CPR
Arm Type
No Intervention
Arm Description
No activation of mobile positioning system to locate and recruit lay responders to nearby OHCAs
Intervention Type
Other
Intervention Name(s)
MLS dispatch for bystander CPR
Primary Outcome Measure Information:
Title
Bystander CPR by trained bystander before arrival of ambulance, firefighters or police
Description
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.
Time Frame
Within 1 hour from randomization
Secondary Outcome Measure Information:
Title
OHCAs were lay volunteers dispatched by the mobile positioning system arriving prior to ambulance
Description
The proportion of mobile phone dispatched lay volunteers arriving prior to ambulance at the scene of the OHCA
Time Frame
Within 1 hour from randomization
Title
Time of bystander CPR before arrival of ambulance, firefighters or police
Description
The time of bystander CPR performed by mobile phone dispatched lay volunteer before arrival of ambulance, firefighters or police
Time Frame
Within 1 hour from randomization
Title
Rhythm on first ECG
Description
Defined as the cardiac rhythm recorded on first ECG. Either Ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) or asystole/pulseless electrical activity If defibrillation = VF/VT
Time Frame
Within 1 hour from randomization
Title
Return of spontaneous circulation (ROSC)
Description
The return of circulation after successful CPR that can be felt by palpable puls or blod pressure that can be measured
Time Frame
Within 3 hours from randomization
Title
Admitted alive
Description
Admitted from Emergency to hospital ward (usually ICU) and alive 24 h after admission
Time Frame
24 hours after hospital admission
Title
Alive after 1 month Cerebral Performance Categories (CPC) 1-2
Description
Alive after 30 days with CPC score 1-2. Description: The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact." Good cerebral performance: little to no deficit. Moderate cerebral disability: capable of independent activities of daily life Severe cerebral disability: conscious, but dependent on others for daily support Coma or vegetative state Death or brain death
Time Frame
From OHCA and 30 days
Title
Alive after 1 month CPC 1-2
Description
Alive after 90 days with CPC score 1-2.
Time Frame
From OHCA and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All suspected OHCAs in Stockholm County All EMS treated out of hospital cardiac arrest in Stockholm County were the mobile positioning system is triggered Exclusion Criteria: Traumatic OHCA Children under 8 years of age Suicide Intoxications Obvious signs of death Do not resuscitate orders (DNR)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif Svensson, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology Södersjukhuset
City
Stockholm
State/Province
Stockholm County
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26061836
Citation
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.
Results Reference
derived

Learn more about this trial

The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR

We'll reach out to this number within 24 hrs