The PulsePoint Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01746290|
Recruitment Status : Withdrawn (The intervention (PulsePoint application) could not be implemented in Toronto as planned)
First Posted : December 10, 2012
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Out-of-hospital Cardiac Arrest||Other: PulsePoint notification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||The PulsePoint Smartphone Application: Recruiting Bystanders to Provide Basic Life Support for Victims of Out-of-Hospital Cardiac Arrest|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: PulsePoint notification
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.
Other: PulsePoint notification
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
No Intervention: Usual Care
Patients randomized to the control arm will receive conventional emergency medical dispatching procedures but no PulsePoint notification will be sent to nearby PulsePoint users.
- 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
- 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 ]The performance of cardiopulmonary resuscitation by a bystander to cardiac arrest prior to arrival of professional rescuers
- 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 ]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.
- 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 ]The occurrence of a bystander applying an automated external defibrillator and then applying a defibrillatory shock to the chest of the victim
- Return of Spontaneous Circulation [ Time Frame: Patients are followed until death or discharge from the hospital, an expected average 30 days ]Return of spontaneous circulation, defined as any palpable pulse or measureable blood pressure.
- Survival to hospital discharge [ Time Frame: Patients are followed until death or discharge from hospital, an expected average of 30 days ]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.
- 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 ]The occurrence of a patient surviving to hospital discharge with a Modified Rankin Score of 0, 1 or 2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746290
|Toronto Emergency Medical Services|
|Toronto, Ontario, Canada, M3H 5R9|
|Principal Investigator:||Steven C Brooks, MD MHSc||Queen's University|