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临床试验/NCT01077089
NCT01077089已完成不适用

Effects of Transport on Patients With Traumatic Brain Injury

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Incidence of adverse events during transport.

研究概览

简要总结

Hospitalized patients are often moved from their rooms to other hospital locations, particularly imaging facilities. For patients with traumatic brain injury, such movements may raise the risk of secondary brain injuries. The purpose of this study is to monitor brain injured patients during transport and to measure the resulting changes in intracranial pressure. This will allow for documentation of the frequency of secondary injury and help in understanding their causes.

详细描述

Secondary insults, such as hypoxia and hypotension, may worsen a brain injury. We hypothesize that secondary brain insults may occur frequently during in-hospital transport in patients with traumatic brain injury (TBI). We additionally hypothesize that automated data collection devices used during transport could more reliably document the frequency of these events and help us to understand the causes. During transport of patients with TBI, intracranial pressure and arterial blood pressure will be continuously recorded to a monitor and saved for later analysis. Additional continuous measurements of pulse oximetry, end-tidal carbon dioxide, and mechanical ventilation settings will be made. The study will identify patients at risk for secondary insults, the etiology of these insults, and assist in development of a road map to prevent future incidents.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

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

  • presence of traumatic brain injury and intracranial pressure monitoring
  • requiring mechanical ventilation
  • presence of an indwelling arterial catheter for monitoring blood pressure
  • Age of at least 18 years

排除标准

  • Age less than 18 years
  • diagnosis of brain death
  • non-English speakers
  • prisoners
  • mentally ill persons

结局指标

主要结局

Incidence of adverse events during transport.

时间窗: Each transport event

次要结局

  • Incidence of elevated heart rate during transport.(Each transport event)
  • Incidence of transport events during which SpO2 remains below 90% for 1 minute or longer(Each transport event)
  • Transport events during which systolic blood pressure remains below 90 mmHg for 5 minutes or longer(Each transport event)
  • Transport events during which mean arterial blood pressure remains below 60 mmHg for 5 minutes or longer(Each transport event)
  • Transport events during which intracranial pressure exceeds 20 mmHg for 5 minutes or longer(Each transport event)
  • Transport events during which cerebral perfusion pressure remains below 70 mmHg for 5 minutes or longer(Each transport event)
  • Number of instances of physiological change that require caregiver intervention, such as ventilator manipulation or drug therapy(Each transport event)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rich Branson, M.D.

Professor of Clinical-Geo

University of Cincinnati

研究点 (1)

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