跳至主要内容
临床试验/NCT04806958
NCT04806958
进行中(未招募)
不适用

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

Dr. Steven Brooks5 个研究点 分布在 2 个国家目标入组 340 人2021年6月8日

概览

阶段
不适用
干预措施
PulsePoint notification
疾病 / 适应症
Out-Of-Hospital Cardiac Arrest
发起方
Dr. Steven Brooks
入组人数
340
试验地点
5
主要终点
Proportion of patients receiving bystander resuscitation
状态
进行中(未招募)
最后更新
19天前

概览

简要总结

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).

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2021年6月8日
结束日期
2026年6月30日
最后更新
19天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Dr. Steven Brooks
责任方
Sponsor Investigator
主要研究者

Dr. Steven Brooks

Associate Professor

Queen's University

入排标准

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Conventional Emergency Dispatch PLUS PulsePoint notification

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.

干预措施: PulsePoint notification

Conventional Emergency Dispatch

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.

结局指标

主要结局

Proportion of patients receiving bystander resuscitation

时间窗: 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.

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.

次要结局

  • Proportion of patients receiving bystander CPR (secondary effectiveness outcome)(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.)
  • Proportion of patients receiving bystander defibrillator use (secondary effectiveness outcome)(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.)
  • Proportion of patients receiving bystander defibrillator shock delivered (secondary effectiveness outcome)(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.)
  • Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)(Patients are followed from EMS arrival on scene until arrival at hospital, an expected average of 35 minutes.)
  • Proportion of patients surviving to hospital discharge (secondary effectiveness outcome)(Patients are followed until death or discharge from hospital, an expected average of 30 days.)
  • Proportion of patients surviving to hospital discharge with good functional outcome (secondary effectiveness outcome)(Patients are followed until death or discharge from hospital, an expected average of 30 days.)
  • EMS response time interval (secondary safety outcome)(Expected average of 5 minutes.)
  • EMS on scene time interval (secondary safety outcome)(Expected average of 30 minutes.)
  • Proportion of patients receiving bystander interference with the resuscitation effort (secondary safety outcome)(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.)
  • Number of PulsePoint application downloads (secondary system performance outcomes)(Downloads in the participating communities will be tracked for the duration of the anticipated 2 year patient recruitment time frame.)
  • Number of PulsePoint application users notified (secondary system performance outcome)(This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.)
  • Sensitivity of PulsePoint activation (secondary system performance outcome)(This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.)
  • False positive rate for PulsePoint activation (secondary system performance outcome)(This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.)
  • Proportion of patients receiving bystander defibrillator shock delivered (secondary effectiveness outcome)(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.)
  • Proportion of patients with return of spontaneous circulation (secondary effectiveness outcome)(Patients are followed from EMS arrival on scene until arrival at hospital, an expected average of 35 minutes.)
  • Proportion of patients surviving to hospital discharge (secondary effectiveness outcome)(Patients are followed until death or discharge from hospital, an expected average of 30 days.)
  • Proportion of patients surviving to hospital discharge with good functional outcome (secondary effectiveness outcome)(Patients are followed until death or discharge from hospital, an expected average of 30 days.)
  • EMS response time interval (secondary safety outcome)(Expected average of 5 minutes.)
  • EMS on scene time interval (secondary safety outcome)(Expected average of 30 minutes.)
  • Proportion of patients receiving bystander interference with the resuscitation effort (secondary safety outcome)(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.)
  • Number of PulsePoint application downloads (secondary system performance outcomes)(Downloads in the participating communities will be tracked for the duration of the anticipated 2 year patient recruitment time frame.)
  • Number of PulsePoint application users notified (secondary system performance outcome)(This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.)
  • Sensitivity of PulsePoint activation (secondary system performance outcome)(This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.)
  • False positive rate for PulsePoint activation (secondary system performance outcome)(This will be tracked for each notification event that occurs during the anticipated 2 year accrual time frame.)
  • Proportion of patients receiving bystander CPR (secondary effectiveness outcome)(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.)
  • Proportion of patients receiving bystander defibrillator use (secondary effectiveness outcome)(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.)

研究点 (5)

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