此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Study of Eye Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population

2007年9月21日 更新者:Ohio State University

Intraocular Pressure as a Predictor of Intracranial Pressure in the Acutely Head-Injured Population

The purpose of this study is to determine if the pressure in the eye of a severely head-injured person correlates with the pressure in the person's skull. This is a prospective study of patients aged 18 and older who have experienced a traumatic closed head injury and are intubated either before or during the time they are in the Emergency Department (ED). Identified patients have an eye pressure measurement performed in the trauma bay by an OSU ED physician not involved in their care. Information about their hospital stay, including the first brain pressure measurement if a such a measuring device is used, will be collected. In addition, the outcome of their hospital stay will be recorded.

研究概览

地位

完全的

条件

详细说明

Traumatic brain injury (TBI) is a leading cause of morbidity and mortality in the United States, with an estimated 1.5 million American sustaining a TBI and 50,000 people dying from a TBI each year. While the immediate, or primary, injury causes significant damage, secondary injury is caused by cerebral edema, increased intracranial pressure, and resultant hypoperfusion and ischemia. Elevated intracranial pressure is strongly associated with poor recovery and death; failure to control intracranial pressure is likewise associated with poor outcomes and mortality.

Early detection of elevated ICP allows for the initiation of early therapy. However, patients with significant head injuries are often intubated for airway protection. The sedation required for intubation obscures the ED neurologic exam. Precise measurement of elevated ICP has required invasive monitoring via ventriculostomy. Yet this method is only provided at set institutions with neurosurgical services. Further there are distinct time delays between the trauma occurrence, transportation to a facility with neurosurgical services and placement of ventriculostomies. There is at the forefront, then, to establish non-invasive measures of ICP that are both time efficient and reliable.

Previous studies, including a pilot study conducted at this institution, showed a correlation between intraocular and intracranial pressure. However, this relationship has not been tested in an acute care trauma setting. We propose an observational cohort study of critically injured trauma patients with suspected closed head injury. Patients requiring intubation and mechanical ventilation pose a significant challenge to assess neurologically, as they are almost always sedated and often chemically paralyzed to facilitate airway management. Therefore, it is in this population of intubated trauma patients with suspected head injury that we will evaluate the use of tonometry to predict intracranial pressure from intraocular pressure.

研究类型

观察性的

注册 (实际的)

37

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ohio
      • Columbus、Ohio、美国、43210
        • The Ohio State University Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with suspected acute traumatic head injury
  • Intubated prior to arrival in the Emergency Department or in the Emergency Department, including patients transferred from other facilities

Exclusion Criteria:

  • Too unstable to allow the investigator access to the head of the bed to perform tonometry.
  • Severe ocular or facial trauma such that an intact globe is not accessible
  • Known history of glaucoma
  • Penetrating head injury
  • Patients that undergo operative decompression prior to the placement of an intracranial pressure monitor may be screened in the trauma bay and have an intraocular pressure obtained; however, these patients will not be included in the intraocular / intracranial pressure analysis.
  • Known allergy to latex or tetracaine

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Brian C Hiestand, MD、The Ohio State University Department of Emergency Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2004年6月1日

研究完成 (实际的)

2007年4月1日

研究注册日期

首次提交

2007年9月21日

首先提交符合 QC 标准的

2007年9月21日

首次发布 (估计)

2007年9月24日

研究记录更新

最后更新发布 (估计)

2007年9月24日

上次提交的符合 QC 标准的更新

2007年9月21日

最后验证

2007年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2004H0126

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅