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The PulsePoint Study

Primary Purpose

Out-Of-Hospital Cardiac Arrest, Heart Arrest, Heart Diseases

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PulsePoint notification
Sponsored by
Dr. Steven Brooks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Out-Of-Hospital Cardiac Arrest focused on measuring Cardiac Arrest, Cardiopulmonary Resuscitation, Automated External Defibrillators, Smartphones

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbus Division of FireRecruiting
  • British Columbia Emergency Health ServicesRecruiting
  • Winnipeg Fire Paramedic Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Conventional Emergency Dispatch PLUS PulsePoint notification

Conventional Emergency Dispatch

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)
Defined as any palpable pulse or measurable blood pressure.
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.
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.
EMS response time interval (secondary safety outcome)
Defined as the time interval between the 9-1-1 call and the EMS arrival on scene.
EMS on scene time interval (secondary safety outcome)
Defined as the time interval between the EMS arrival on scene to EMS departure from scene.
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.
Number of PulsePoint application downloads (secondary system performance outcomes)
Defined as the number of PulsePoint application downloads in each participating community.
Number of PulsePoint application users notified (secondary system performance outcome)
The number of application users notified for each PulsePoint notification.
Sensitivity of PulsePoint activation (secondary system performance outcome)
The sensitivity of the PulsePoint activation as it relates to activation for true cardiac arrests.
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.

Full Information

First Posted
March 16, 2021
Last Updated
June 28, 2023
Sponsor
Dr. Steven Brooks
Collaborators
University of British Columbia, BC Emergency Health Services, Winnipeg Fire Paramedic Service, University of Manitoba, University of Toronto, Ohio State University, Columbus Division of Fire, PulsePoint Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04806958
Brief Title
The PulsePoint Study
Official Title
Evaluating the PulsePoint Mobile Device Application to Increase Bystander Resuscitation for Victims of Sudden Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Steven Brooks
Collaborators
University of British Columbia, BC Emergency Health Services, Winnipeg Fire Paramedic Service, University of Manitoba, University of Toronto, Ohio State University, Columbus Division of Fire, PulsePoint Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases
Keywords
Cardiac Arrest, Cardiopulmonary Resuscitation, Automated External Defibrillators, Smartphones

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants, EMS providers, dispatch providers, treating physicians will be blinded
Allocation
Randomized
Enrollment
522 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Emergency Dispatch PLUS PulsePoint notification
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Emergency Dispatch
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PulsePoint notification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients receiving bystander resuscitation
Description
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.
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.
Secondary Outcome Measure Information:
Title
Proportion of patients receiving bystander CPR (secondary effectiveness outcome)
Description
Defined as the occurrence of bystander CPR (chest compressions and or ventilations) prior to the arrival of emergency medical services.
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.
Title
Proportion of patients receiving bystander defibrillator use (secondary effectiveness outcome)
Description
Defined as bystander application of defibrillator pads on the chest of the victim prior to the arrival of emergency medical services.
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.
Title
Proportion of patients receiving bystander defibrillator shock delivered (secondary effectiveness outcome)
Description
Defined as the occurrence of a bystander applying an automated external defibrillator and then applying a defibrillatory shock to the chest of the victim.
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.
Title
Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)
Description
Defined as any palpable pulse or measurable blood pressure.
Time Frame
Patients are followed from EMS arrival on scene until arrival at hospital, an expected average of 35 minutes.
Title
Proportion of patients surviving to hospital discharge (secondary effectiveness outcome)
Description
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.
Time Frame
Patients are followed until death or discharge from hospital, an expected average of 30 days.
Title
Proportion of patients surviving to hospital discharge with good functional outcome (secondary effectiveness outcome)
Description
Defined as the occurrence of a patient surviving to hospital discharge with a Modified Rankin Score of 0,1, 2 or 3.
Time Frame
Patients are followed until death or discharge from hospital, an expected average of 30 days.
Title
EMS response time interval (secondary safety outcome)
Description
Defined as the time interval between the 9-1-1 call and the EMS arrival on scene.
Time Frame
Expected average of 5 minutes.
Title
EMS on scene time interval (secondary safety outcome)
Description
Defined as the time interval between the EMS arrival on scene to EMS departure from scene.
Time Frame
Expected average of 30 minutes.
Title
Proportion of patients receiving bystander interference with the resuscitation effort (secondary safety outcome)
Description
Defined as emergency medical service crew reports of bystander interference with the resuscitation effort.
Time Frame
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.
Title
Number of PulsePoint application downloads (secondary system performance outcomes)
Description
Defined as the number of PulsePoint application downloads in each participating community.
Time Frame
Downloads in the participating communities will be tracked for the duration of the anticipated 2 year patient recruitment time frame.
Title
Number of PulsePoint application users notified (secondary system performance outcome)
Description
The number of application users notified for each PulsePoint notification.
Time Frame
This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
Title
Sensitivity of PulsePoint activation (secondary system performance outcome)
Description
The sensitivity of the PulsePoint activation as it relates to activation for true cardiac arrests.
Time Frame
This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.
Title
False positive rate for PulsePoint activation (secondary system performance outcome)
Description
The false positive rate for PulsePoint activation resulting from activation of the system for conditions other than cardiac arrest.
Time Frame
This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven C Brooks, MD MHSc
Phone
613-549-6666
Ext
7497
Email
Steven.Brooks@kingstonhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Brooks, MD MHSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John M Tallon, MD MSc
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbus Division of Fire
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Lowe, MD
Phone
614-724-0538
Email
RALowe@columbus.gov
First Name & Middle Initial & Last Name & Degree
Ashish Panchal, MD, PhD
First Name & Middle Initial & Last Name & Degree
Robert Lowe, MD
Facility Name
British Columbia Emergency Health Services
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5M 4X6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Jenneson, MD
Email
Sandra.Jenneson@bcehs.ca
First Name & Middle Initial & Last Name & Degree
Sandra Jenneson, MD
First Name & Middle Initial & Last Name & Degree
Jennie S. Helmer, M.Ed.
Facility Name
Winnipeg Fire Paramedic Service
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3B 1J1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rob Grierson, MD
Phone
204-986-3192
Email
rgrierson@winnipeg.ca
First Name & Middle Initial & Last Name & Degree
Rob Grierson, MD
First Name & Middle Initial & Last Name & Degree
Erin Weldon, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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