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临床试验/NCT02191514
NCT02191514已完成不适用

Prehospital Management of Stroke Patients by Emergency Medical Services - an Evaluation of Emergency Medical Dispatch and Ambulance Personnel.

Emergency Medical Services, Capital Region, Denmark1 个研究点 分布在 1 个国家目标入组 2,653 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,653
试验地点
1
主要终点
Time from departure from the scene of the accident to arrival at the stroke centre in stroke fast track patients.

研究概览

简要总结

Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is available, but only 12% of stroke patients receive it.

The treatment is only available within a time frame of 4,5 hours from symptom onset, thus the Emergency Medical Services (EMS) is essential to fast and effective stroke treatment.

The aim of this study is:

  1. To establish the rate of recognition of stroke symptoms by healthcare personnel in the EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast and correct EMS-response.
  2. To assess prehospital time consumption by ambulance personnel on the scene of a stroke, create a baseline for future comparison and generate explorative hypotheses for forthcoming interventions.

The overall aim of this study is, to ensure the best possible prehospital care for all stroke patients. The study will determine, if the EMD is at a high and international level in regards to stroke recognition, and if there is a potential to decrease on-scene time. This will serve as future comparison and have an effect on the structure and future education in the prehospital services, and potentially improve the outcome after acute ischemic stroke.

详细描述

Background:

Approximately 12.000 strokes occur in Denmark annually. The only evidence based pharmacological treatment of ischemic stroke is thrombolysis within a time-window of 4.5 hours from symptom onset(1). In 2012, 12% of patients with ischemic stroke in Denmark received thrombolysis treatment. The probability of a favourable 3-month outcome after stroke decreases with time from symptom onset to thrombolysis: the onset to needle time(2). Therefore, it is of the highest importance to identify potential targets for prehospital time reduction, and thereby reduce delay to definitive care.

Prompt recognition of stroke symptoms by both the EMD and ambulance personnel is a crucial step, as it provides access to fast track acute stroke services. In this context, the role of the EMS is essential, as contact to the hospital through EMS opposed to private transport is correlated to decreased onset-to-door time (3). EMS prenotification of the stroke centre is correlated to shorter door-to-evaluation time, door-to-needle time and onset-to-needle time(4). In Denmark EMS prenotification in acute stroke is well established.

According to Danish guidelines for treatment of acute stroke and transient ischaemic attack (TIA), prehospital diagnosis of stroke is improved by use of validated tests. No such is yet implemented in the Capital Region of Denmark.

Preliminary data shows that the mean time from the ambulance personnel arrives at the scene to they start the transport to the hospital ("on scene time") is 18 minutes in the Capital Region of Denmark. American guidelines suggest that on-scene-time should be less than 15 minutes in all cases (unless extenuating circumstances or extrication difficulties are present)(1), however the organisation of stroke care between Scandinavia and USA varies largely.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients are included if registered in Danish Stroke Registry with an ICD-10 code of stroke (haemorrhagic and ischemic - I61 and I63-64.9), in the National Patient Registry with an ICD-10 code of TIA (Transient Ischemic Attack - G45.9) or in the Emergency Medical Services-database with a dispatch code of suspected stroke (A.26.03, A.26.04) from the 2-year period 01-01-2012 - 12-31-2013.

排除标准

  • Patients are excluded if the Danish personal identification number is not available in either database. If the patient has been directly referred to the hospital by their general practitioner without the use of a EMS transport, or they have presented themselves in the emergency room, they will not be registered in the EMS database.
  • Inclusion Criteria:
  • Patients with suspected stroke where the EMS has been in contact with fast track stroke service at the stroke centre are included.
  • Exclusion Criteria:
  • Incomplete forms will be excluded.
  • Inclusion Criteria:
  • All patients with a Danish personal identification number, referred to one of the two regional stroke centres, during a 6-month period will be included. The 6 month period will begin after the above mentioned 500 registration form has been collected, to avoid bias.
  • Exclusion Criteria:

结局指标

主要结局

Time from departure from the scene of the accident to arrival at the stroke centre in stroke fast track patients.

时间窗: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

The rate of acute stroke recognized by the EMD during the emergency call (sensitivity).

时间窗: 01.01.2012 - 12.31.2013 (up to 24 months)

Time from dispatch to ambulance arrival at the scene of accident in stroke fast track patients.

时间窗: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

Time on scene by EMS in stroke fast track patients (on-scene-time).

时间窗: Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

次要结局

  • Final diagnoses(ICD-10), in patients with a dispatch code of stroke, but another final diagnosis (false positive).(01.01.2012 - 12.31.2013 (up to 24 months))
  • The proportion of patients with a final diagnosis of stroke, who accessed the healthcare system through the EMS.(01.01.2012 - 12.31.2013 (up to 24 months))
  • Prehospital time compared to in-hospital time in stroke fast track patients.(Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015))
  • Dispatch codes, in patients with a final diagnosis of acute stroke, but another dispatch code (false negative).(01.01.2012 - 12.31.2013 (up to 24 months))
  • The positive predictive values of stroke recognition by healthcare personnel at the EMD.(01.01.2012 - 12.31.2013 (up to 24 months))
  • Recognition of stroke by EMD in relation to treatment decisions in stroke fast track patients(Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015))

研究者

发起方
Emergency Medical Services, Capital Region, Denmark
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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