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临床试验/NCT04110912
NCT04110912撤回不适用

Improving Outcomes After Time Sensitive Prehospital Interventions: Rescu Epistry

Unity Health Toronto3 个研究点 分布在 1 个国家开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
3
主要终点
Data Registry

研究概览

简要总结

Rescu Epistry includes data points pertaining to prehospital and in-hospital clinical treatments and responses to therapy, survival to discharge and functional outcome data for all cases.

详细描述

The prehospital component of health care begins with a call to 911 and ends on arrival to the Emergency Department (ED). In Ontario, prehospital care is provided by a system which includes 22 dispatch centres, 218 Fire and 72 Emergency Medical Services (EMS) who respond to over 1 million 911 calls a year. The prehospital setting is a chaotic, unpredictable environment in which to deliver care and currently there is no data on whether or not this system of care makes a difference in patient outcomes. The question: are the right patients, receiving the right care and making it to the right institutions cannot readily be answered. Outcome-based information to guide future EMS care has been hampered by the lack of comprehensive prehospital data resources that include meaningful patient outcomes.

Why target cardiac arrest, trauma, acute stroke, and sepsis? Ischaemic heart disease is the leading cause of death worldwide, and second leading cause of death in Canada; over 240,000 deaths from heart disease annually. The mean age of cardiac arrest patients is around 65 years of age and this demographic is increasing over time with the population older than 65 expected to double within the next 25 years such that by 2041 about 1 in 4 Canadians will be 65 or older.

Trauma is the number one cause of death and disability in people younger than 40 and confirmed for Canada as well for those under the age of 45. Trauma statistics are biased by the fact that the only data we have comes from the trauma centres and this means a trauma victim must survive long enough to make it to a trauma centre to be counted.

Stroke is the second leading cause of death worldwide, and the leading cause of chronic disability. Stroke is most frequently caused by an interruption of blood supply to portions of the brain due to occlusion of a major brain artery. Stroke statistics have the same bias as trauma statistics. The current registries for trauma and stroke (national and provincial) are administrative data sets containing only patients that are treated at a stroke or trauma centre and miss all those that are treated and released from community centres that are located close enough to a stroke or trauma centre to be subject to a community bypass strategy or referral. Nor do these data sets capture the important prehospital data on the event and time sensitive interventions provided in the prehospital setting.

Sepsis is a clinical syndrome that results from dysregulation of the inflammatory response to severe infection. As sepsis progresses to septic shock it is marked by severe organ dysfunction, coagulopathy, and eventually circulatory collapse and death. The mortality associated with sepsis syndrome ranges from 20 to 50% with increased mortality in patients diagnosed with severe sepsis and septic shock. The average prehospital care interval exceeded 45 minutes, highlighting that there is great potential for early treatment to be delivered by paramedics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Cardiac Arrest Eligibility
  • Individuals of all ages who experience cardiac arrest outside the hospital, with evaluation by organized EMS personnel and:
  • Attempts at external defibrillation (by lay responders or emergency personnel), or chest compressions by organized EMS personnel (treated cohort)
  • Were pulseless but did not receive attempts to defibrillate or CPR by EMS personnel (untreated cohort - obviously dead by legislative definition)
  • Traumatic Injury Eligibility
  • Individuals of all ages who experience a traumatic injury outside the hospital, with evaluation by organized EMS personnel and:
  • Systolic blood pressure ≤ 90 mmHg or
  • Glasgow Coma Scale score ≤12 or
  • Respiratory rate <10 or >29 breaths per minute or
  • Field intubation/advanced airway procedure
  • Stroke Eligibility
  • individuals of all ages who experience stroke outside the hospital, with evaluation by organized EMS personnel and new onset of signs and symptoms suggestive of an acute stroke
  • Unilateral arm/leg weakness or drift or
  • Slurred speech or inappropriate words or mute or
  • Unilateral facial droop
  • Sepsis Eligibility
  • Potentially Septic: Individuals of all ages who present with
  • Presence of Fever: Temperature >38°C (tympanic membrane)
  • Paramedic suspects possible infection: i.e. suspected pneumonia, urinary tract infection, abdominal pain or distension, meningitis, cellulitis, septic arthritis, infected wound (minimal data set )
  • Severe Sepsis: Individuals of all ages who also present with:
  • Presence of Fever: Temperature >38°C (tympanic membrane)
  • Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tract infection, abdominal pain or distension, meningitis, cellulitis, septic arthritis, infected wound; Presence of any one of: (1) respiratory rate > 22/min or intubated for respiratory support; (2) acute confusion or reduced level of consciousness; (3) presence of hypotension: SBP<=100mmHg (comprehensive data set)

排除标准

  • 未提供

结局指标

主要结局

Data Registry

时间窗: 1 year (annual)

To collect comprehensive, standardized, multicentre prehospital data to guide future EMS and Fire as well as in-hospital care (e.g. Emergency Department (ED), Trauma Room, Critical Care Units (CrCU), ward care and rehabilitation) for cardiac arrest, trauma, stroke, and sepsis patients.

次要结局

  • Effectiveness and Translation(1 year (annual))
  • Evaluation(1 year (annual))
  • International Collaboration in both Efficacy and Effectiveness(1 year (annual))
  • Examine epidemiologic and outcomes(1 year (annual))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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