We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The PulsePoint Randomized Controlled Trial

This study has been withdrawn prior to enrollment.
(The intervention (PulsePoint application) could not be implemented in Toronto as planned)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746290
First Posted: December 10, 2012
Last Update Posted: November 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Steven Brooks, Queen's University
November 12, 2012
December 10, 2012
November 26, 2015
January 2013
November 2015   (Final data collection date for 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 ]
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
Same as current
Complete list of historical versions of study NCT01746290 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Out-of-hospital Cardiac Arrest
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
  • 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.
    Intervention: Other: PulsePoint notification
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2015
November 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01746290
228304
No
Not Provided
Not Provided
Dr. Steven Brooks, Queen's University
Queen's University
Heart and Stroke Foundation of Ontario
Principal Investigator: Steven C Brooks, MD MHSc Queen's University
Queen's University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP