NCT04806958

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).

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Jun 2021Jun 2026

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

March 16, 2021

Last Update Submit

April 8, 2026

Conditions

Out-Of-Hospital Cardiac ArrestHeart ArrestHeart DiseasesCardiovascular Diseases

Keywords

Cardiac ArrestCardiopulmonary ResuscitationAutomated External DefibrillatorsSmartphones

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients receiving bystander resuscitation

    Defined as the occurrence of either bystander CPR (chest compressions and or ventilations) or bystander application of a defibrillator prior to the arrival of emergency medical services.

    Patients will be followed for this outcome during the interval from 9-1-1 call to emergency medical services arrival, an expected average of 5 minutes.

Secondary Outcomes (13)

  • Proportion of patients receiving bystander CPR (secondary effectiveness outcome)

    Patients will be followed for this outcome during the interval from 9-1-1 call to emergency medical services arrival, an expected average of 5 minutes.

  • Proportion of patients receiving bystander defibrillator use (secondary effectiveness outcome)

    Patients will be followed for this outcome during the interval from 9-1-1 call to emergency medical services arrival, an expected average of 5 minutes.

  • Proportion of patients receiving bystander defibrillator shock delivered (secondary effectiveness outcome)

    Patients will be followed for this outcome during the interval from 9-1-1 call to emergency medical services arrival, an expected average of 5 minutes.

  • Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)

    Patients are followed from EMS arrival on scene until arrival at hospital, an expected average of 35 minutes.

  • Proportion of patients surviving to hospital discharge (secondary effectiveness outcome)

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

  • +8 more secondary outcomes

Study Arms (2)

Conventional Emergency Dispatch PLUS PulsePoint notification

EXPERIMENTAL

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.

Other: PulsePoint notification

Conventional Emergency Dispatch

NO INTERVENTION

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.

Interventions

PulsePoint notificationOTHER

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 PLUS PulsePoint notification

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with 911 calls assigned as "suspected" or "confirmed" cardiac arrest and,
  • Are confirmed to be EMS-treated, public location out-of-hospital cardiac arrest.

You may not qualify if:

  • Traumatic cardiac arrest, or
  • Cardiac arrests occurring in the context of a dangerous scene as determined by the 9-1-1 call-taker, or
  • EMS-witnessed cardiac arrest, or
  • Cardiac arrests not treated by EMS ("Do Not Resuscitate", signs of obvious death), or
  • Cardiac arrests occurring in nursing homes and health care facilities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbus Division of Fire

Columbus, Ohio, 43207, United States

Location

British Columbia Emergency Health Services

Vancouver, British Columbia, V5M 4X6, Canada

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Steven C Brooks, MD MHSc

    Queen's University

    PRINCIPAL INVESTIGATOR

  • John M Tallon, MD MSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, EMS providers, dispatch providers, treating physicians will be blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 19, 2021

Study Start

June 8, 2021

Primary Completion

March 27, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(1)