The PulsePoint Randomized Controlled Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Queen's University
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Steven Brooks, Queen's University
ClinicalTrials.gov Identifier:
NCT01746290
First received: November 12, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

"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.


Condition Intervention
Out-of-hospital Cardiac Arrest
Other: PulsePoint notification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The occurrence of a patient surviving to hospital discharge with a Modified Rankin Score of 0, 1 or 2.


Estimated Enrollment: 861
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746290

Contacts
Contact: Tyrone Pereirra, MSc 416-864-6060 ext 7851 perreiraT@smh.ca
Contact: Steven C Brooks, MD MHSc 613-549-6666 ext 7497 brookss1@kgh.kari.net

Locations
Canada, Ontario
Toronto Emergency Medical Services Not yet recruiting
Toronto, Ontario, Canada, M3H 5R9
Contact: Dan Cottom       dcottom@toronto.ca   
Sponsors and Collaborators
Queen's University
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Steven C Brooks, MD MHSc Queen's University
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Brooks, Clinician-Scientist, Queen's University
ClinicalTrials.gov Identifier: NCT01746290     History of Changes
Other Study ID Numbers: 228304
Study First Received: November 12, 2012
Last Updated: December 7, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014