Clinical trial NCT04806958: The PulsePoint Study
Official title: Evaluating the PulsePoint Mobile Device Application to Increase Bystander Resuscitation for Victims of Sudden Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Keywords: Cardiac Arrest
Cardiopulmonary Resuscitation
Automated External Defibrillators
Smartphones
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: BC Emergency Health Services
name: Winnipeg Fire Paramedic Service
name: University of Manitoba
name: University of Toronto
name: Ohio State University
name: Columbus Division of Fire
name: PulsePoint Foundation
First posted: 2021-03-19
Enrollment: 340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Proportion of patients receiving bystander resuscitation
timeFrame: 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:
measure: Proportion of patients receiving bystander CPR (secondary effectiveness outcome)
timeFrame: 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.
measure: Proportion of patients receiving bystander defibrillator use (secondary effectiveness outcome)
timeFrame: 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.
measure: Proportion of patients receiving bystander defibrillator shock delivered (secondary effectiveness outcome)
timeFrame: 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.
measure: Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)
timeFrame: Patients are followed from EMS arrival on scene until arrival at hospital, an expected average of 35 minutes.
measure: Proportion of patients surviving to hospital discharge (secondary effectiveness outcome)
timeFrame: Patients are followed until death or discharge from hospital, an expected average of 30 days.
measure: Proportion of patients surviving to hospital discharge with good functional outcome (secondary effectiveness outcome)
timeFrame: Patients are followed until death or discharge from hospital, an expected average of 30 days.
measure: EMS response time interval (secondary safety outcome)
timeFrame: Expected average of 5 minutes.
measure: EMS on scene time interval (secondary safety outcome)
timeFrame: Expected average of 30 minutes.
measure: Proportion of patients receiving bystander interference with the resuscitation effort (secondary safety outcome)
timeFrame: 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.
measure: Number of PulsePoint application downloads (secondary system performance outcomes)
timeFrame: Downloads in the participating communities will be tracked for the duration of the anticipated 2 year patient recruitment time frame.
measure: Number of PulsePoint application users notified (secondary system performance outcome)
timeFrame: This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
measure: Sensitivity of PulsePoint activation (secondary system performance outcome)
timeFrame: This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
measure: False positive rate for PulsePoint activation (secondary system performance outcome)
timeFrame: This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Division of Fire
state: Ohio
city: Vancouver
country: Canada
facility: British Columbia Emergency Health Services
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Fire Paramedic Service
state: Manitoba
Study officials:
affiliation: Queen's University
name: Steven C Brooks, MD MHSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John M Tallon, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: