Out-of-Hospital Cardiac ArrestRUMBANCT01789554
The Use of Mobile Phones in Out of Hospital Cardiac Arrest to Increase Bystander CPR
A study testing MLS dispatch for bystander CPR in people with Out-of-Hospital Cardiac Arrest and Death, Sudden, Cardiac, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac, Heart Diseases
- What is being tested?
- MLS dispatch for bystander CPR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Dec 2013
- 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 suspected OHCAs in Stockholm County
- All EMS treated out of hospital cardiac arrest in Stockholm County were the mobile positioning system is triggered
Who cannot join
- Traumatic OHCA
- Children under 8 years of age
- Suicide
- Intoxications
- Obvious signs of death
- Do not resuscitate orders (DNR)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology Södersjukhuset
Stockholm, Stockholm County, 11883
About this study
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.
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 %
Read the 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.
- Conditions
- Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac, Heart Diseases, Ventricular Fibrillation
- Being tested
- MLS dispatch for bystander CPR
- Keywords
- Out of hospital cardiac arrest, Cardiopulmonary resuscitation, Bystander CPR, Mobile phone positioning system
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac, Heart Diseases, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLS dispatch for bystander CPROther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 hour from randomization
Secondary outcomes (7)
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
Measured: Within 1 hour from randomization
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
Measured: Within 1 hour from randomization
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
Measured: Within 1 hour from randomization
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
Measured: Within 3 hours from randomization
Admitted alive
Admitted from Emergency to hospital ward (usually ICU) and alive 24 h after admission
Measured: 24 hours after hospital 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
Measured: From OHCA and 30 days
Alive after 1 month CPC 1-2
Alive after 90 days with CPC score 1-2.
Measured: From OHCA and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leif Svensson, Karolinska Institutet
- Investigators
- Leif Svensson, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789554
- Sponsor's protocol ID
- RUMBA2013
- Acronym
- RUMBA
- Status last verified
- Sep 2014
- First submitted
- 6 Feb 2013
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26061836
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01789554
- Acronym / sponsor ID
- RUMBA / RUMBA2013
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Feb 2013 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLS dispatch for bystander CPR | Experimental | Other: MLS dispatch for bystander CPRWhen 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 MLS dispatch for bystander CPR | No intervention | –No activation of mobile positioning system to locate and recruit lay responders to nearby OHCAs |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All suspected OHCAs in Stockholm County
- All EMS treated out of hospital cardiac arrest in Stockholm County were the mobile positioning system is triggered
Key exclusion criteria (6 listed)
- Traumatic OHCA
- Children under 8 years of age
- Suicide
- Intoxications
- Obvious signs of death
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 |
|---|---|---|
| MLS dispatch for bystander CPR | Other | MLS dispatch for bystander CPR |
Primary outcome
Bystander CPR by trained bystander before arrival of ambulance, firefighters or police
Time frame: Within 1 hour from randomization
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.
7 secondary outcomes
OHCAs were lay volunteers dispatched by the mobile positioning system arriving prior to ambulance
Time frame: Within 1 hour from randomization
Time of bystander CPR before arrival of ambulance, firefighters or police
Time frame: Within 1 hour from randomization
Rhythm on first ECG
Time frame: Within 1 hour from randomization
Return of spontaneous circulation (ROSC)
Time frame: Within 3 hours from randomization
Admitted alive
Time frame: 24 hours after hospital admission
Alive after 1 month Cerebral Performance Categories (CPC) 1-2
Time frame: From OHCA and 30 days
Alive after 1 month CPC 1-2
Time frame: From OHCA and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Derived from this study: PubMed 26061836Ringh 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.
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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, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MLS dispatch for bystander CPR in people with Out-of-Hospital Cardiac Arrest and Death, Sudden, Cardiac, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 11 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bystander CPR by trained bystander before arrival of ambulance, firefighters or police (time frame: Within 1 hour from randomization). 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 NCT01789554, 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 11 Sep 2014.