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临床试验/NCT06672757
NCT06672757尚未招募不适用

Use of App for Stroke Assessment VS Standard Level of Care During Prehospital Stroke Assessment

Naestved Hospital2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2024年10月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,200
试验地点
2
主要终点
Prehospital recognition of stroke

研究概览

简要总结

In Denmark, 12,000 people experience a stroke every year. It is the fourth largest cause of death, and costs 4,6 billion Danish crowns in healthcare expenses and lost work income. It is also the leading cause of acquired disability for adults. Pre-hospital recognition of stroke is paramount to ensure fast and correct treatment for patients, in turn leading to better outcomes for patients. As the advanced treatment for ischemic stroke, thrombolysis and thrombectomy, is time-sensitive, even short delays in recognition and treatment can have a large effect on the individual stroke patient.

Paramedics on scene have only a few tools to assist them in recognizing stroke, where clinical scales such as the National Institutes of Health Stroke Scale (NIHSS), Face Arm Speech Time (FAST) or Prehospital Stroke Score (PRESS ) are most commonly used. Despite the use of such instruments, patients with stroke still go unrecognized, and as a result, the unrecognized patient might not be hospitalized, be hospitalized in a hospital without stroke facilities or be hospitalized too late for advanced treatment. Lower quality of communication between paramedics and the stroke centre significantly increases prehospital on-scene time. In a consensus statement from the European Academy of Neurology (EAN) and the European Stroke Organisation (ESO), training paramedics to recognise symptoms of all stroke types was strongly recommended. This study aims to explore whether trained paramedics using a mobile application with NIHSS and video communication to the in-hospital stroke physician may improve triage of acute stroke patients. This intervention will be compared to paramedics using standard procedure and communication through regular channels. It is hypothesized that the number of patients brought to the emergency department with suspected acute stroke and discharged with a stroke diagnosis is significantly higher in the app-group (intervention) compared to standard prehospital model (control).

详细描述

  1. Background 1.1 Stroke In Denmark, 12,000 people experience a stroke every year. It is the fourth largest cause of death, and costs 4,6 billion Danish crowns in healthcare expenses and lost work income. It is also the leading cause of acquired disability for adults.

Pre-hospital recognition of stroke is paramount to ensure fast and correct treatment for patients, in turn leading to better outcomes for patients. As the advanced treatment for ischemic stroke, thrombolysis and thrombectomy, is time-sensitive, even short delays in recognition and treatment can have a large effect on the individual stroke patient. Paramedics on scene have only a few tools to assist them in recognizing stroke, where clinical scales such as the National Institutes of Health Stroke Scale (NIHSS), Face Arm Speech Time (FAST) or Prehospital Stroke Score (PRESS ) are most commonly used. Despite the use of such instruments, patients with stroke still go unrecognized, and as a result, the unrecognized patient might not be hospitalized, be hospitalized in a hospital without stroke facilities or be hospitalized too late for advanced treatment.

A combination of early prehospital identification of stroke, triage to the right level of care and improvement of in-hospital measures to reduce door-to-needle time may result in more patients receiving acute treatment. Lower quality of communication between paramedics and the stroke centre significantly increases prehospital on-scene time. In a consensus statement from the European Academy of Neurology (EAN) and the European Stroke Organisation (ESO), training paramedics to recognise symptoms of all stroke types was strongly recommended.

This study aims to explore whether trained paramedics using a mobile application with NIHSS and digital communication may improve triage of acute stroke patients and ensure the standardised transfer of critical patient data to the in-hospital stroke physician. This intervention will be compared to paramedics using standard procedure with PRESS and communication through regular channels.

Investigators hypothesize that the number of patients brought to the emergency department (ED) with suspected acute stroke and discharged with a stroke diagnosis is significantly higher in the app-group (intervention) compared to standard prehospital model (control).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • A. Suspected stroke by paramedic or dispatcher

排除标准

  • Technical issues (ie. the telephone does not work, the app does not work).
  • Patients who are incarcerated
  • Patients seen by a physician prior to assessment by paramedics.
  • Subarachnoid Haemorrhage strokes

结局指标

主要结局

Prehospital recognition of stroke

时间窗: From enrollment to patient admission upto 6 hours

The primary outcome will be prehospital recognition of stroke by paramedics, quantified as the proportion of patients discharged with a final stroke diagnosis who are accepted for stroke evaluation by the neurologist at the neurovascular centre.

次要结局

  • Time on scene(From enrollment to the admission upto 6 hours)
  • Change in 90-day neurological outcome measured by the modified rankin scale (mRS)(90 days after admission)
  • Door-to-scanner time(From enrollment to the admission upto 12 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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