The PulsePoint Study

NCT ID: NCT04806958

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2026-06-30

Brief Summary

This randomized controlled trial will evaluate whether use of the PulsePoint system increases bystander CPR or defibrillator use compared to standard dispatch procedures in patients who suffer non-traumatic, out-of-hospital cardiac arrest in a public location. Half of all suspected cardiac arrest 9-1-1 calls in a public location will receive PulsePoint alerts (treatment arm). The other half of this eligible patient cohort will receive standard dispatch procedures (control arm).

Detailed Description

Out-of-hospital cardiac arrest (OHCA) is a major public health problem. More than 45,000 Canadians suffer OHCA annually, with only 8.4% surviving to hospital discharge. Early bystander cardiopulmonary resuscitation (CPR) and defibrillator use can save lives but are rarely done.

Advances in mobile device technology have allowed the development of a system which can notify CPR-trained citizens within 400 meters of a possible cardiac arrest. The PulsePoint mobile device application (www.pulsepoint.org) empowers them to respond and provide basic life support while professional crews are being dispatched. When a mobile device receives the alert data from the PulsePoint system, the application presents a map showing the exact location of the emergency and the closest public access defibrillator.

PulsePoint will be implemented in 2 regions across Canada and the US (British Columbia and Columbus, Ohio). After a coordinated marketing campaign in each participating region to maximize the number of mobile device application downloads in the community, 9-1-1 calls for suspected cardiac arrest will be randomized to conventional dispatch for suspected cardiac arrest versus conventional dispatch plus PulsePoint notifications. The primary outcome will be bystander CPR or defibrillator use prior to professional responders arriving on scene. The primary analysis will involve comparing outcomes between the control and treatment groups among randomized patients who satisfy inclusion and exclusion criteria and have at least one PulsePoint responder within 400 meters of the cardiac arrest event.

The investigators hypothesize that the PulsePoint system will have an immediate impact on increasing bystander CPR and defibrillator use in participating communities. In the long term, this project will provide valuable data on how effective PulsePoint is with respect to bystander resuscitation and survival. The data will directly inform policy decisions about PulsePoint implementation in the participating communities and guide other North American jurisdictions around these policy decisions in the future.

Conditions

Out-Of-Hospital Cardiac Arrest; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Conventional Emergency Dispatch PLUS PulsePoint notification

Eligible 911 calls randomized to the experimental arm of the study will undergo usual dispatch of emergency services personnel as per pre-existing local protocols and activation of the PulsePoint system. When triggered, the system will push location data to all PulsePoint mobile application users within 400 meters of the emergency. Devices receiving the alerts from the PulsePoint system will alarm with auditory, tactile and visual stimuli. The application will present a map showing the exact location of the emergency and the closest public access defibrillator.

Group Type: EXPERIMENTAL

PulsePoint notification

Intervention Type: OTHER

The PulsePoint interface software monitors each 9-1-1 call on dispatch computers and is automatically triggered by particular conditions including call type (e.g. suspected cardiac arrest) and location type (public location). When triggered, the system pushes location data to all PulsePoint mobile application users within 400 meters of the emergency location.

When a mobile device running the PulsePoint Respond application receives the alert data from the PulsePoint system, the device alarms with auditory, tactile (vibration) and visual stimuli. The application presents a map showing the exact location of the suspected cardiac arrest and the closest public access defibrillator.

Conventional Emergency Dispatch

Patients randomized to the control arm will receive conventional emergency medical dispatching procedures as per pre-existing local protocols (e.g. dispatch of emergency vehicles, attempted dispatch-assisted CPR) without activation of the PulsePoint system. 911 calls randomized to the control arm will not be associated with any PulsePoint alerts.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PulsePoint notification

The PulsePoint interface software monitors each 9-1-1 call on dispatch computers and is automatically triggered by particular conditions including call type (e.g. suspected cardiac arrest) and location type (public location). When triggered, the system pushes location data to all PulsePoint mobile application users within 400 meters of the emergency location.

When a mobile device running the PulsePoint Respond application receives the alert data from the PulsePoint system, the device alarms with auditory, tactile (vibration) and visual stimuli. The application presents a map showing the exact location of the suspected cardiac arrest and the closest public access defibrillator.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with 911 calls assigned as "suspected" or "confirmed" cardiac arrest and,

2. Are confirmed to be EMS-treated, public location out-of-hospital cardiac arrest.

Exclusion Criteria

1. Traumatic cardiac arrest, or

2. Cardiac arrests occurring in the context of a dangerous scene as determined by the 9-1-1 call-taker, or

3. EMS-witnessed cardiac arrest, or

4. Cardiac arrests not treated by EMS ("Do Not Resuscitate", signs of obvious death), or

5. Cardiac arrests occurring in nursing homes and health care facilities.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

BC Emergency Health Services

UNKNOWN

Sponsor Role: collaborator

Winnipeg Fire Paramedic Service

UNKNOWN

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Columbus Division of Fire

UNKNOWN

Sponsor Role: collaborator

PulsePoint Foundation

UNKNOWN

Sponsor Role: collaborator

Dr. Steven Brooks

OTHER

Sponsor Role: lead

Responsible Party

Dr. Steven Brooks

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven C Brooks, MD MHSc

Role: PRINCIPAL_INVESTIGATOR

Queen's University

John M Tallon, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Columbus Division of Fire

Columbus, Ohio, United States

Site Status: RECRUITING

British Columbia Emergency Health Services

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Winnipeg Fire Paramedic Service

Winnipeg, Manitoba, Canada

Site Status: WITHDRAWN

Countries

United States; Canada

Central Contacts

Steven C Brooks, MD MHSc

Role: CONTACT

Steven.Brooks@kingstonhsc.ca

613-549-6666 ext. 7497

Facility Contacts

Robert Lowe, MD

Role: primary

RALowe@columbus.gov

614-724-0538

Sandra Jenneson, MD

Role: primary

Sandra.Jenneson@bcehs.ca

Other Identifiers

148168

Identifier Type: -

Identifier Source: org_study_id