The PulsePoint Study

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806958
• Other study ID #: 148168
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2023
• Source: Queen's University
• Contact: Steven C Brooks, MD MHSc
• Phone: 613-549-6666
• Email: Steven.Brooks[@]kingstonhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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 3 regions across Canada and the US (British Columbia, Winnipeg, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 522
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Arrest
• Heart Diseases
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	British Columbia Emergency Health Services	Vancouver	British Columbia
Canada	Winnipeg Fire Paramedic Service	Winnipeg	Manitoba
United States	Columbus Division of Fire	Columbus	Ohio

Sponsors (9)

Lead Sponsor	Collaborator
Dr. Steven Brooks	BC Emergency Health Services, Columbus Division of Fire, Ohio State University, PulsePoint Foundation, University of British Columbia, University of Manitoba, University of Toronto, Winnipeg Fire Paramedic Service

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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	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.	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	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.	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	Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)	Defined as any palpable pulse or measurable blood pressure.	Patients are followed from EMS arrival on scene until arrival at hospital, an expected average of 35 minutes.
Secondary	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.	Patients are followed until death or discharge from hospital, an expected average of 30 days.
Secondary	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 Modified Rankin Score of 0,1, 2 or 3.	Patients are followed until death or discharge from hospital, an expected average of 30 days.
Secondary	EMS response time interval (secondary safety outcome)	Defined as the time interval between the 9-1-1 call and the EMS arrival on scene.	Expected average of 5 minutes.
Secondary	EMS on scene time interval (secondary safety outcome)	Defined as the time interval between the EMS arrival on scene to EMS departure from scene.	Expected average of 30 minutes.
Secondary	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.	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.
Secondary	Number of PulsePoint application downloads (secondary system performance outcomes)	Defined as the number of PulsePoint application downloads in each participating community.	Downloads in the participating communities will be tracked for the duration of the anticipated 2 year patient recruitment time frame.
Secondary	Number of PulsePoint application users notified (secondary system performance outcome)	The number of application users notified for each PulsePoint notification.	This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
Secondary	Sensitivity of PulsePoint activation (secondary system performance outcome)	The sensitivity of the PulsePoint activation as it relates to activation for true cardiac arrests.	This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
Secondary	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.	This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.