The PulsePoint Randomized Controlled Trial

NCT01746290 | Withdrawn

• 1 other identifier: 228304
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-of-hospital Cardiac Arrest

Keywords

Cardiac Arrest, cardiopulmonary resuscitation, automated external defibrillators, smartphones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Bystander CPR

  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

  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

  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

  Patients are followed until death or discharge from the hospital, an expected average 30 days

• Survival to hospital discharge

  Patients are followed until death or discharge from hospital, an expected average of 30 days

Study Arms (2)

PulsePoint notification

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

PulsePoint notification OTHER

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

PulsePoint notification

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Toronto Emergency Medical Services

Toronto, Ontario, M3H 5R9, Canada

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Steven C Brooks, MD MHSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

CA (1)