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临床试验/NCT03036020
NCT03036020已完成不适用

The Norwegian Acute Stroke Prehospital Project

Kristi G. Bache, PhD1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Inter-rated agreement between the anesthesiologist and the inhospital stroke team (radiologist and neurologist)

研究概览

简要总结

The main aim of the NASPP study is to assess the efficacy and safety of the prehospital diagnosis of stroke using the Norwegian stroke ambulance concept. NASPP aims to demonstrate that anesthesiologists trained in pre-hospital critical care may perform acute stroke diagnostics by clinical assessment and CT scan interpretation and integrating these skills in the already existing organizational frame of the Norwegian prehospital EMS system.

NASPP will systematically explore the Norwegian model of prehospital acute stroke diagnostics prior to the implementation of prehospital thrombolytic stroke treatment. NASSP will equip a regular ambulance staffed with a specially trained anesthesiologist and a specialized nurse. NASPP will perform the clinical part of the study in close co-operation with Østfold Hospital, Fredrikstad.

详细描述

Background Stroke is the third leading cause of death in most western countries, and the major cause of adult disability leaving two thirds of stroke survivors struggling with moderate to severe disability. Stroke affects approximately 15 million people worldwide each year.

Up to 90% of all strokes are ischemic (cerebral infarction), mostly due to an acute thromboembolic obstruction of a cerebral artery, whereas around 10 % of strokes are cerebral hemorrhages. Acute ischemic stroke must be considered as a medical emergency, and early recanalization of the obstructed artery must be attempted. The intravenous drug alteplase (Actilyse®), a recombinant human tissue type plasminogen activator, is approved for use within 4.5 hours after symptom start of an ischemic stroke. The earlier treatment is initiated, however, the better odds for of a good outcome.

A cerebral infarction cannot be differentiated from a cerebral hemorrhage without neuroradiological investigation. If a patient with acute cerebral hemorrhage is treated with thrombolysis it may be fatal. Therefore, and contrary to the setting of a cardiac infarction, intravenous thrombolysis of cerebral infarction has to be performed in-hospital after computer tomography (CT), or magnetic resonance imaging (MRI), scanning of the brain. The consequence of this obligatory radiological examination is an unavoidable time delay and very few ischemic stroke patients are actually treated within "the golden 90 minutes" after symptom onset. The only way to avoid this, for the brain, detrimental time delay is logical; to establish the diagnosis of ischemic stroke outside the hospital and in time as near symptom onset as possible. Subsequently this will open the possibility for very early prehospital thrombolytic treatment for a much higher number of patients.

Minimizing prehospital time delay has been proven to positively influence thrombolytic rates in acute ischemic stroke. However, a recent study with a telemedicine-equipped ambulance (telestroke ambulance) has shown that prehospital real-time stroke severity assessment by hospital-based stroke physicians during ambulance transport does not have a technical acceptable stability for clinical use. In this Berlin study using "actor stroke patients" in a moving ambulance, an acceptable clinical evaluation of only 40% of the patients was achieved. A recent clinical stroke study from the University Saarland, Germany has, however, demonstrated that the concept of prehospital stroke diagnosis is feasible. Using a specially designed mobile stroke unit (MSU), a car ambulance equipped with a stroke neurologist, a CT scanner and a point of care biochemical laboratory, time from symptom onset to diagnostic therapeutic decision for thrombolysis was reduced from 76 to 35 minutes. The CT scanner in the MSU was shown to provide brain scans of high quality in 95% of cases allowing differentiation of cerebral infarction and cerebral hemorrhage. No safety radiation issues occurred for either staff or patients.

The time delay in stroke diagnostics may be reduced with early radiological diagnosis, but there is also need of reliable clinical recognition of stroke symptoms. The reliability of the National Institutes of Health Stroke Scale (NIHSS) is established by several clinical trials when performed by trained neurologists. Dewey et al proved in a 1999 trial "Inter-rater reliability of the National Institutes of Health Stroke scale: Rating by Neurologists and Nurses in a Community-Based stroke Incidence study" that the overall agreement in NIHSS scoring between trained nurses and a trained neurologists were no different from the agreement between neurologists. The study suggested that trained nurses could administer the NIHSS with reliability similar to stroke- trained neurologists.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients met by emergency services within 4 hours after symptom onset
  • Stroke symptoms: sudden weakness of leg or arm, especially on one side, facial asymmetry and/or sudden trouble walking, and speech disturbance (Norwegian Index of medical emergencies 27.03-27.05).
  • Patients from the Hospital dispatch center area, being more than 10-15 minutes drive from the hospital.
  • Giving informed consent, written or oral, if possible or consent from relative at site

排除标准

  • Age under 18 years
  • Pregnancy
  • Female < 50 years and uncertainty of pregnancy

结局指标

主要结局

Inter-rated agreement between the anesthesiologist and the inhospital stroke team (radiologist and neurologist)

时间窗: Baseline

The ambulance anesthesiologist assesses the pre-hospital cerebral CT scan and fills out the predefined variables in designated study forms. All cerebral CT interpreations are categorized in 1) no radiological contraindication to thrombolytics 2) yes radiological contraindication to thrombolytics. The CT scan is simultaneously sent to the hospital, for interpretation by the neurologist and the radiologist on call. The anesthesiologist intgerpration is blinded to the stroke team. A neuroradiologist will, without any clinical knowledge, review the CT scans after the study has included is completed. The results from the initial interpretation by the ambulance anesthesiologist are held anonymous, and blinded for the neuroradiologist. The results will be analyzed statistically to show distribution of the different categories of inter-rater agreement, compared to the neurologists and radiologists at the admission hospital.

次要结局

未报告次要终点

研究者

发起方
Kristi G. Bache, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kristi G. Bache, PhD

Head of Research Department at The Norwegian Air Ambulance Foundation

Norwegian Air Ambulance Foundation

研究点 (1)

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