AzTrials
AzTrials

Out-Of-Hospital Cardiac ArrestNCT04806958

The PulsePoint Study

A study testing PulsePoint notification in people with Out-Of-Hospital Cardiac Arrest and Heart Arrest, run by Dr. Steven Brooks at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
PulsePoint notification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
2 sitesin 2 countries
Study dates
8 Jun 2021to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Columbus Division of Fire

    Columbus, Ohio, 43207

Other trials in United States

Canada1 site
  • British Columbia Emergency Health Services

    Vancouver, British Columbia, V5M 4X6

Other trials in Canada

About this study

Official title: Evaluating the PulsePoint Mobile Device Application to Increase Bystander Resuscitation for Victims of Sudden Cardiac Arrest

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).

Read the 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.

Being tested
PulsePoint notification
Keywords
Cardiac Arrest, Cardiopulmonary Resuscitation, Automated External Defibrillators, Smartphones
Medical subject headings
Out-of-Hospital Cardiac Arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04806958
Study groupRoleWhat they receive
Conventional Emergency Dispatch PLUS PulsePoint notificationExperimentalEligible 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.
Receives: Other: PulsePoint notification
Conventional Emergency DispatchNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Proportion of patients receiving bystander CPR (secondary effectiveness outcome)

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

    Measured: 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.

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

    Defined as bystander application of defibrillator pads on the chest of the victim prior to the arrival of emergency medical services.

    Measured: 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.

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

    Defined as the occurrence of a bystander applying an automated external defibrillator and then applying a defibrillatory shock to the chest of the victim.

    Measured: 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.

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

    Defined as any palpable pulse or measurable blood pressure.

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

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

    Defined as 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.

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

  6. Proportion of patients surviving to hospital discharge with good functional outcome (secondary effectiveness outcome)

    Defined as the occurrence of a patient surviving to hospital discharge with a Cerebral Performance Score of 1 or 2.

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

  7. EMS response time interval (secondary safety outcome)

    Defined as the time interval between the 9-1-1 call and the EMS arrival on scene.

    Measured: Expected average of 5 minutes.

  8. EMS on scene time interval (secondary safety outcome)

    Defined as the time interval between the EMS arrival on scene to EMS departure from scene.

    Measured: Expected average of 30 minutes.

  9. Proportion of patients receiving bystander interference with the resuscitation effort (secondary safety outcome)

    Defined as emergency medical service crew reports of bystander interference with the resuscitation effort.

    Measured: Patients will be followed for this outcome in the time interval between 9-1-1 call and EMS departure from scene, an expected average of 35 minutes.

  10. Number of PulsePoint application downloads (secondary system performance outcomes)

    Defined as the number of PulsePoint application downloads in each participating community.

    Measured: Downloads in the participating communities will be tracked for the duration of the anticipated 2 year patient recruitment time frame.

  11. Number of PulsePoint application users notified (secondary system performance outcome)

    The number of application users notified for each PulsePoint notification.

    Measured: This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.

  12. Sensitivity of PulsePoint activation (secondary system performance outcome)

    The sensitivity of the PulsePoint activation as it relates to activation for true cardiac arrests.

    Measured: This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.

  13. False positive rate for PulsePoint activation (secondary system performance outcome)

    The false positive rate for PulsePoint activation resulting from activation of the system for conditions other than cardiac arrest.

    Measured: This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2021
  2. Study start8 Jun 2021
  3. Primary completion27 Mar 2026
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04806958
Sponsor's protocol ID
148168
Status last verified
Apr 2026
First submitted
16 Mar 2021
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PulsePoint notification in people with Out-Of-Hospital Cardiac Arrest and Heart Arrest, run by Dr. Steven Brooks at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients receiving bystander resuscitation (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in