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The PulsePoint Randomized Controlled Trial

Primary Purpose

Out-of-hospital Cardiac Arrest

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PulsePoint notification
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Out-of-hospital Cardiac Arrest focused on measuring Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Toronto Emergency Medical Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PulsePoint notification

Usual Care

Arm Description

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.

Patients randomized to the control arm will receive conventional emergency medical dispatching procedures but no PulsePoint notification will be sent to nearby PulsePoint users.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bystander CPR
The performance of cardiopulmonary resuscitation by a bystander to cardiac arrest prior to arrival of professional rescuers
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.
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
Return of Spontaneous Circulation
Return of spontaneous circulation, defined as any palpable pulse or measureable blood pressure.
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.
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.

Full Information

First Posted
November 12, 2012
Last Updated
November 24, 2015
Sponsor
Queen's University
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT01746290
Brief Title
The PulsePoint Randomized Controlled Trial
Official Title
The PulsePoint Smartphone Application: Recruiting Bystanders to Provide Basic Life Support for Victims of Out-of-Hospital Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
The intervention (PulsePoint application) could not be implemented in Toronto as planned
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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%. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest
Keywords
Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PulsePoint notification
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients randomized to the control arm will receive conventional emergency medical dispatching procedures but no PulsePoint notification will be sent to nearby PulsePoint users.
Intervention Type
Other
Intervention Name(s)
PulsePoint notification
Intervention Description
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
Primary Outcome Measure Information:
Title
Bystander Resuscitation
Description
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
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
Secondary Outcome Measure Information:
Title
Bystander CPR
Description
The performance of cardiopulmonary resuscitation by a bystander to cardiac arrest prior to arrival of professional rescuers
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
Title
Bystander AED use
Description
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.
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
Title
Bystander AED shock
Description
The occurrence of a bystander applying an automated external defibrillator and then applying a defibrillatory shock to the chest of the victim
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
Title
Return of Spontaneous Circulation
Description
Return of spontaneous circulation, defined as any palpable pulse or measureable blood pressure.
Time Frame
Patients are followed until death or discharge from the hospital, an expected average 30 days
Title
Survival to hospital discharge
Description
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.
Time Frame
Patients are followed until death or discharge from hospital, an expected average of 30 days
Title
Survival to hospital discharge with good functional outcome
Description
The occurrence of a patient surviving to hospital discharge with a Modified Rankin Score of 0, 1 or 2.
Time Frame
Patients are followed unitl death or discharge from hospital, an expected average of 30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Brooks, MD MHSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Emergency Medical Services
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5R9
Country
Canada

12. IPD Sharing Statement

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The PulsePoint Randomized Controlled Trial

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