PulsePoint App for Cardiac Arrest

Recruiting at 1 trial location

Overseen By Steven C Brooks, MD MHSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Steven Brooks

Disqualifiers: Traumatic cardiac arrest, dangerous scene, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 2 years

340 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the PulsePoint App treatment for cardiac arrest?

Research shows that the PulsePoint Respond app helps notify nearby citizens to provide basic life support, like CPR, for cardiac arrest patients before emergency responders arrive, potentially improving survival rates. ^{1 2 3 4 5}

Is the PulsePoint App safe for use in humans?

The available research does not provide specific safety data for the PulsePoint App, but it is designed to notify nearby citizens to assist in emergencies, which suggests it is generally safe as it does not involve direct medical intervention. ^{1 5 6 7 8}

How is the PulsePoint App treatment for cardiac arrest different from other treatments?

The PulsePoint App is unique because it uses a mobile application to notify nearby citizens to provide basic life support, like CPR, to someone experiencing cardiac arrest before professional help arrives. This crowdsourcing approach is different from traditional treatments that rely solely on emergency medical services. ^{1 2 5 6 9}

What is the purpose of this trial?

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).

Research Team

John M Tallon, MD MSc

Principal Investigator

University of British Columbia

Steven C Brooks, MD MHSc

Principal Investigator

Queen's University

Eligibility Criteria

The PulsePoint Study is for patients who experience a non-traumatic, out-of-hospital cardiac arrest in public. They must be treated by EMS and have their condition confirmed as 'suspected' or 'confirmed' cardiac arrest. It excludes those with traumatic arrests, arrests at dangerous scenes, EMS-witnessed events, cases not treated by EMS (like DNRs), or incidents in nursing homes/healthcare facilities.

Inclusion Criteria

I had a cardiac arrest in a public place and was treated by EMS.

Exclusion Criteria

My cardiac arrest was traumatic, in a dangerous place, witnessed by EMS, or I wasn't treated due to a DNR.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized controlled trial evaluating the PulsePoint system to increase bystander CPR or defibrillator use

2 years

Continuous monitoring during 9-1-1 calls

Follow-up

Participants are monitored for survival to hospital discharge and other outcomes

30 days

Data Analysis

Analysis of data to evaluate the effectiveness of the PulsePoint system

6 months

Treatment Details

Interventions

• PulsePoint notification

Trial Overview This study tests if the PulsePoint system can increase bystander CPR or defibrillator use when someone has a cardiac arrest in public. Participants are randomly divided into two groups: one receives PulsePoint alerts plus standard dispatch; the other gets only standard dispatch.

Participant Groups

Group I: Conventional Emergency Dispatch PLUS PulsePoint notification Experimental Treatment 1 Intervention

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 II: Conventional Emergency Dispatch Active Control 1 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.

PulsePoint notification is already approved in United States, Canada for the following indications:

Approved in United States as PulsePoint Respond for:

• Non-traumatic, out-of-hospital cardiac arrest in public locations

Approved in Canada as PulsePoint Respond for:

• Non-traumatic, out-of-hospital cardiac arrest in public locations

Who Is Running the Clinical Trial?

Dr. Steven Brooks

Lead Sponsor

Trials

1

Recruited

340+

Dr. Steven Brooks

Lead Sponsor

Trials

1

Recruited

340+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Columbus Division of Fire

Collaborator

Trials

1

Recruited

340+

PulsePoint Foundation

Collaborator

Trials

1

Recruited

340+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

BC Emergency Health Services

Collaborator

Trials

2

Recruited

12,600+

Winnipeg Fire Paramedic Service

Collaborator

Trials

1

Recruited

340+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

A survey of 2415 participants from Canada and the United States showed that a vast majority (over 96%) support the implementation of the PulsePoint Respond app for crowdsourcing basic life support during cardiac arrests.

Most respondents expressed willingness to download the app and respond to alerts, with 84% of Canadians and 56% of Americans indicating they would do so, highlighting a strong public interest in enhancing emergency response through technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

North American Public Opinion Survey on the Acceptability of Crowdsourcing Basic Life Support for Out-of-Hospital Cardiac Arrest With the PulsePoint Mobile Phone App. Dainty, KN., Vaid, H., Brooks, SC.[2019]

A pilot study involving 9 students tested a smartphone alerting system that uses GPS to automatically measure the departure times of volunteers responding to cardiac arrest alerts, showing that this method is feasible and precise.

The study found that the median difference between automatically recorded departure times and manually recorded times was minimal, indicating that GPS can effectively track responder times, especially with a 20-meter geofence, which had the least variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic measurement of departing times in smartphone alerting systems: A pilot study. Ganter, J., Ruf, A., Oppermann, J., et al.[2023]

The revised dispatcher-assisted CPR (DA-CPR) protocol significantly improved the recognition of cardiac arrests (from 54.5% to 68.8%) and the checking of normal breathing (from 51.5% to 76.6%) among dispatchers, indicating better training and response during emergencies.

After implementing the DA-CPR protocol, there was a notable increase in 24-hour survival rates for out-of-hospital cardiac arrest patients (from 7.6% to 20.3%), suggesting that the protocol may enhance patient outcomes in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Dispatch Protocol with Continuous Quality Control for Cardiac Arrest: A Before-and-After Study at a City Fire Department-Based Dispatch Center. Huang, CH., Fan, HJ., Chien, CY., et al.[2018]

The Code Blue Leader smartphone app significantly improved the performance scores of ACLS-trained medical professionals during cardiac arrest simulations, with an average score of 95.3% compared to 81.4% in the control group.

The app users performed 100% of critical actions required during the simulations, while the control group only achieved 85%, indicating that the app enhances adherence to essential protocols in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a smartphone-based cognitive aid on clinical performance during cardiac arrest simulations: A randomized controlled trial. Brophy, SL., McCue, MR., Reel, RM., et al.[2023]

Only 23% of users who received a PulsePoint Respond notification actually responded, highlighting a significant challenge in engaging bystanders for cardiac arrest situations.

Despite the low response rate, 79% of those who arrived at the scene of a cardiac arrest performed bystander CPR, indicating that when individuals do respond, they are likely to take action to help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PulsePoint Respond mobile device application to crowdsource basic life support for patients with out-of-hospital cardiac arrest: Challenges for optimal implementation. Brooks, SC., Simmons, G., Worthington, H., et al.[2016]

The Citizen app provided notifications about traumatic cardiac arrest an average of 12.9 minutes earlier than traditional emergency medical services notifications, which could significantly improve response times and potentially patient outcomes.

The app successfully generated notifications for 84% of the patients studied, indicating its reliability as a secondary source of information for emergency responders in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving out-of-hospital notification in traumatic cardiac arrests with novel usage of smartphone application. Kelly, GS., Clare, D.[2022]

The augmented reality (AR) CPR feedback system significantly improved chest compression performance in community emergency departments, with 87-90% of compressions meeting the goal range compared to only 18-21% without feedback.

Qualitative feedback from participants indicated that AR-CPR was easy to use, helped reduce anxiety, and increased confidence in delivering effective CPR, suggesting it could be a valuable tool in non-pediatric-specialized settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Chest Compression Improvement Via Augmented Reality Cardiopulmonary Resuscitation Feedback in Community General Emergency Departments: A Mixed-Methods Simulation-Based Pilot Study. Kleinman, K., Hairston, T., Smith, B., et al.[2023]

In a study involving 9,000 registered volunteers over two years in Limburg, Netherlands, the novel text message system for notifying citizen rescuers was activated in about 49% of out-of-hospital cardiac arrests (OHCAs), indicating a need for better activation in emergencies.

Survival rates for cardiac arrest victims improved significantly with higher volunteer density, rising from 20.6% to 34.8% when the density of citizen rescuers exceeded 0.75%, highlighting the importance of increasing the number of trained volunteers for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of a novel citizen rescue system for out-of-hospital cardiac arrest in the Dutch province of Limburg: relation to incidence and survival. Pijls, RWM., Nelemans, PJ., Rahel, BM., et al.[2020]

The study analyzed 593 out-of-hospital cardiac arrests and found that using a mobile app to alert first responders significantly reduced the time to arrival on scene (3.5 minutes) compared to SMS alerts (5.6 minutes).

The mobile app also increased the likelihood of lay responders arriving first at the scene (70% vs. 15%), which is crucial since quicker CPR initiation is linked to higher survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lay persons alerted by mobile application system initiate earlier cardio-pulmonary resuscitation: A comparison with SMS-based system notification. Caputo, ML., Muschietti, S., Burkart, R., et al.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

North American Public Opinion Survey on the Acceptability of Crowdsourcing Basic Life Support for Out-of-Hospital Cardiac Arrest With the PulsePoint Mobile Phone App. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Automatic measurement of departing times in smartphone alerting systems: A pilot study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Validation of a Dispatch Protocol with Continuous Quality Control for Cardiac Arrest: A Before-and-After Study at a City Fire Department-Based Dispatch Center. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The impact of a smartphone-based cognitive aid on clinical performance during cardiac arrest simulations: A randomized controlled trial. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

The PulsePoint Respond mobile device application to crowdsource basic life support for patients with out-of-hospital cardiac arrest: Challenges for optimal implementation. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Improving out-of-hospital notification in traumatic cardiac arrests with novel usage of smartphone application. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric Chest Compression Improvement Via Augmented Reality Cardiopulmonary Resuscitation Feedback in Community General Emergency Departments: A Mixed-Methods Simulation-Based Pilot Study. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Characteristics of a novel citizen rescue system for out-of-hospital cardiac arrest in the Dutch province of Limburg: relation to incidence and survival. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Lay persons alerted by mobile application system initiate earlier cardio-pulmonary resuscitation: A comparison with SMS-based system notification. [2018]