The PulsePoint Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Out-of-hospital Cardiac Arrest
• Intervention / Treatment: Other: PulsePoint notification

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3H 5R9
      • Toronto Emergency Medical Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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),
2. Out-of-hospital cardiac arrest as defined within the ROC Epistry Database

Exclusion Criteria:

1. Trauma (including burns) associated with cardiac arrest
2. Cardiac arrests occurring in prisons, etc
3. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bystander CPR	The performance of cardiopulmonary resuscitation by a bystander to cardiac arrest prior to arrival of professional rescuers	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.	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	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.	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.	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.	Patients are followed unitl death or discharge from hospital, an expected average of 30 days

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Heart and Stroke Foundation of Ontario
• Investigators: Principal Investigator: Steven C Brooks, MD MHSc, Queen's University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 12, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 24, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 228304