The PulsePoint Randomized Controlled Trial

Out-of-hospital Cardiac Arrest Clinical Trial

Official title:

The PulsePoint Smartphone Application: Recruiting Bystanders to Provide Basic Life Support for Victims of Out-of-Hospital Cardiac Arrest

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01746290
• Other study ID #: 228304
• Status: Withdrawn
• Phase: N/A
• First received: November 12, 2012
• Last updated: November 24, 2015
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Emergency Medical Services	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No