Out-of-hospital Cardiac ArrestNCT01746290
The PulsePoint Randomized Controlled Trial
A study testing PulsePoint notification in people with Out-of-hospital Cardiac Arrest, run by Queen's University at 1 site in Canada.
Trial summary
"Sudden cardiac arrest" occurs when someone's heart stops beating unexpectedly. Each year, more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve survival: Call 911,start chest compressions and apply a defibrillator. Together, these actions can increase survival by up to 800%. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- PulsePoint notification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Nov 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with 911 calls assigned MPDS code 09-E-01 (Suspected atraumatic cardiac arrest not breathing), and 09-E-02 (Suspected cardiac arrest, not breathing normally),
- Out-of-hospital cardiac arrest as defined within the ROC Epistry Database
Who cannot join
- Trauma (including burns) associated with cardiac arrest
- Cardiac arrests occurring in prisons, etc
- Patients not treated by paramedics because of a DNR order or signs of obvious death as per Ontario provincial paramedic medical directives (e.g. decapitation, decomposition, rigour mortis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PulsePoint Smartphone Application: Recruiting Bystanders to Provide Basic Life Support for Victims of Out-of-Hospital Cardiac Arrest
"Sudden cardiac arrest" occurs when someone's heart stops beating unexpectedly. Each year, more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve survival: Call 911,start chest compressions and apply a defibrillator. Together, these actions can increase survival by up to 800%. The problem is that bystanders to cardiac arrest only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3 of every 100 cardiac arrest cases. There are many people in the community who are trained and willing to provide help for cardiac arrest victims such as off-duty paramedics, fire fighters, nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of these people is nearby, but unaware of the emergency. The PulsePoint smartphone application enables these people to be notified by the local emergency 911 service when there is a cardiac arrest near to them. It can be freely downloaded to several common types of smartphones. When there is a cardiac arrest emergency, all nearby PulsePoint users are sent an alert from the 911 service. When the phones receive the alert, they ring, vibrate and display a text message saying "CPR NEEDED". The user's current location and the exact location of the cardiac arrest are then displayed on a map. Nearby public access AEDs are also indicated on the map. The smartphone users can then go to provide chest compressions and use an AED while paramedics are on their way. A video at www.pulsepoint.org shows how this works. The objective of the investigators is to measure whether the PulsePoint smartphone application increases bystander CPR or AED use for victims of cardiac arrest outside the hospital. This project will happen in the City of Toronto. The investigators have a plan to get as many people as possible to download the application, focusing on health care professionals who know CPR. The investigators will set up a webpage that helps people download the software to their phone. The investigators will randomize 911 calls to have a PulsePoint alert sent or not. The investigators will use statistical analysis to measure whether sending an alert to a smartphone increases the chances of bystander resuscitation.
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- PulsePoint notification
- Keywords
- Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulsePoint notificationOther
When the smartphone receives the alert data, the phone alarms with auditory, tactile (vibration) and visual stimuli (Figure 1). After acknowledgement of the alert by the user, the application presents a map and text information to direct the user to the exact location of the emergency. Using local AED registry data, the application can also reveal exact AED locations in the vicinity of the emergency
| Study group | Role | What they receive |
|---|---|---|
| PulsePoint notification | Experimental | Conventional Emergency Dispatch PLUS The PulsePoint notification. In the event of a potential cardiac arrest identified by 911call-takers, data will be automatically pushed to PulsePoint smartphone application users within very close proximity to the emergency. This will be done in parallel with normal emergency dispatch of paramedics and fire fighters to the scene of the emergency. The activation radius around the emergency is somewhat variable, depending on phone signal strength, climate conditions and whether the phone is inside or outside, but is approximately 200-500 meters. Receives: Other: PulsePoint notification |
| Usual Care | No intervention | Patients randomized to the control arm will receive conventional emergency medical dispatching procedures but no PulsePoint notification will be sent to nearby PulsePoint users. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bystander Resuscitation
Bystander Resuscitation is defined as the occurrence of a bystander performing cardiopulmonary resuscitation or applying an automated external defibrillator to the chest of the subject prior to the arrival of professional rescuers
Measured: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Secondary outcomes (6)
Bystander CPR
The performance of cardiopulmonary resuscitation by a bystander to cardiac arrest prior to arrival of professional rescuers
Measured: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Bystander AED use
The use of an automated external defibrillator by a bystander prior to the arrival of professional rescuers. Automated external defibrillator use is defined as the application of the electrical pads of the machine to the chest of the victim.
Measured: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Bystander AED shock
The occurrence of a bystander applying an automated external defibrillator and then applying a defibrillatory shock to the chest of the victim
Measured: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Return of Spontaneous Circulation
Return of spontaneous circulation, defined as any palpable pulse or measureable blood pressure.
Measured: Patients are followed until death or discharge from the hospital, an expected average 30 days
Survival to hospital discharge
Survival of a patient to the point of discharge from the acute care hospital. Discharge may be to a residence or long term care facility.
Measured: Patients are followed until death or discharge from hospital, an expected average of 30 days
Survival to hospital discharge with good functional outcome
The occurrence of a patient surviving to hospital discharge with a Modified Rankin Score of 0, 1 or 2.
Measured: Patients are followed unitl death or discharge from hospital, an expected average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: The intervention (PulsePoint application) could not be implemented in Toronto as planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Dr. Steven Brooks, Queen's University
- Investigators
- Steven C Brooks, MD MHSc, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746290
- Sponsor's protocol ID
- 228304
- Status last verified
- Nov 2015
- First submitted
- 12 Nov 2012
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PulsePoint Smartphone Application: Recruiting Bystanders to Provide Basic Life Support for Victims of Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01746290
- Acronym / sponsor ID
- 228304
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The intervention (PulsePoint application) could not be implemented in Toronto as planned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Dec 2012 (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.
"Sudden cardiac arrest" occurs when someone's heart stops beating unexpectedly. Each year, more than 45,000 Canadians have a cardiac arrest. A bystander can do three things to improve survival: Call 911,start chest compressions and apply a defibrillator. Together, these actions can increase survival by up to 800%. The problem is that bystanders to cardiac arrest only provide CPR in about 3 of every 10 cardiac arrest cases and AED use in about 3 of every 100 cardiac arrest cases. There are many people in the community who are trained and willing to provide help for cardiac arrest victims such as off-duty paramedics, fire fighters, nurses, etc. When a cardiac arrest occurs in the city, it is likely that one of these people is nearby, but unaware of the emergency. The PulsePoint smartphone application enables these people to be notified by the local emergency 911 service when there is a cardiac arrest near to them. It can be freely downloaded to several common types of smartphones. When there is a cardiac arrest emergency, all nearby PulsePoint users are sent an alert from the 911 service. When the phones receive the alert, they ring, vibrate and display a text message saying "CPR NEEDED". The user's current location and the exact location of the cardiac arrest are then displayed on a map. Nearby public access AEDs are also indicated on the map. The smartphone users can then go to provide chest compressions and use an AED while paramedics are on their way. A video at www.pulsepoint.org shows how this works. The objective of the investigators is to measure whether the PulsePoint smartphone application increases bystander CPR or AED use for victims of cardiac arrest outside the hospital. This project will happen in the City of Toronto. The investigators have a plan to get as many people as possible to download the application, focusing on health care professionals who know CPR. The investigators will set up a webpage that helps people download the software to their phone. The investigators will randomize 911 calls to have a PulsePoint alert sent or not. The investigators will use statistical analysis to measure whether sending an alert to a smartphone increases the chances of bystander resuscitation.
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 |
|---|---|---|
| PulsePoint notification | Experimental | Other: PulsePoint notificationConventional Emergency Dispatch PLUS The PulsePoint notification. In the event of a potential cardiac arrest identified by 911call-takers, data will be automatically pushed to PulsePoint smartphone application users within very close proximity to the emergency. This will be done in parallel with normal emergency dispatch of paramedics and fire fighters to the scene of the emergency. The activation radius around the emergency is somewhat variable, depending on phone signal strength, climate conditions and whether the phone is inside or outside, but is approximately 200-500 meters. |
| Usual Care | No intervention | –Patients randomized to the control arm will receive conventional emergency medical dispatching procedures but no PulsePoint notification will be sent to nearby PulsePoint users. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with 911 calls assigned MPDS code 09-E-01 (Suspected atraumatic cardiac arrest not breathing), and 09-E-02 (Suspected cardiac arrest, not breathing normally),
- Out-of-hospital cardiac arrest as defined within the ROC Epistry Database
Key exclusion criteria (3 listed)
- Trauma (including burns) associated with cardiac arrest
- Cardiac arrests occurring in prisons, etc
- Patients not treated by paramedics because of a DNR order or signs of obvious death as per Ontario provincial paramedic medical directives (e.g. decapitation, decomposition, rigour mortis)
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 |
|---|---|---|
| PulsePoint notificationWhen the smartphone receives the alert data, the phone alarms with auditory, tactile (vibration) and visual stimuli (Figure 1). After acknowledgement of the alert by the user, the application presents a map and text information to direct the user to the exact location of the emergency. Using local AED registry data, the application can also reveal exact AED locations in the vicinity of the emergency | Other | PulsePoint notification |
Primary outcome
Bystander Resuscitation
Time frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Bystander Resuscitation is defined as the occurrence of a bystander performing cardiopulmonary resuscitation or applying an automated external defibrillator to the chest of the subject prior to the arrival of professional rescuers
6 secondary outcomes
Bystander CPR
Time frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Bystander AED use
Time frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Bystander AED shock
Time frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes
Return of Spontaneous Circulation
Time frame: Patients are followed until death or discharge from the hospital, an expected average 30 days
Survival to hospital discharge
Time frame: Patients are followed until death or discharge from hospital, an expected average of 30 days
Survival to hospital discharge with good functional outcome
Time frame: Patients are followed unitl death or discharge from hospital, an expected average of 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
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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.
Steven C Brooks, MD MHSc principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulsePoint notification in people with Out-of-hospital Cardiac Arrest, run by Queen's University at 1 site in Canada.
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 3 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: withdrawn, as of the sponsor's last update on 26 Nov 2015. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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 Resuscitation (time frame: Patients will be followed for this outcome during the interval from 911 call to emergency medical services arrival, an expected average of 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2015.