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临床试验/NCT07838350
NCT07838350已完成不适用

Validity of Quantitative Pupillometry in Neurocritical Care and Correlation With Intracranial Pressure : an Observational, Uni-institutional Study

Walton Centre NHS Foundation Trust0 个研究点目标入组 9 人开始时间: 2020年1月7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
9
主要终点
Hourly Pupil response

研究概览

简要总结

Traumatic Brain Injury is a leading cause of death and disability in adults worldwide. The investigators want to find the best way to predict which patients with head injuries are going to deteriorate in order to get medical treatment promptly. Pupil examination is an essential part of a neurological assessment, providing a window in to the brain. Abnormalities in measurement of pupil size and response to light indicates rising pressure inside the rigid skull (intracranial pressure (ICP)), which results in significant death and disability.

详细描述

Traumatic brain injury (TBI) is a leading cause of death and disability in adults worldwide. Severe TBI, defined as a Glasgow Coma Score (GCS) 8, is associated with mortality as high as 30-40%. It is established that the major determinant of outcome following TBI and target of medical interventions is secondary brain injury, primarily cerebral ischaemia. It is due to a combination of intracranial hypertension (ICH), systemic hypotension, hypoxia, hyperpyrexia, hypercapnia and hypoglycaemia, all have been shown to independently worsen survival after TBI. ICH refers to rise in pressure inside the rigid skull (intracranial pressure (ICP)), which reduces blood flow and oxygen to the brain. ICP values over 20-25mmHg are indicative of ICH. Accordingly, treatment of these patients centres on controlling ICP, improving cerebral blood flow (CBF) and oxygenation.

Monitoring pupil size and its light reflex mechanism is an integral part of non-invasive clinical monitoring in patients with severe brain injury in NCCUs globally. Abnormalities in pupillary response or size asymmetry are associated with neurological deterioration and poor outcome. In addition, studies have shown a strong correlation with brainstem oxygenation and blood flow.

A study evaluating pupil response and ICP showed that changes in pupils were detected even in patients with normal ICP. Crucially, they suggested that abnormalities in posterior frontal and temporal regions of the brain may occur even when the ICP is normal. Given the indispensable role of these parameters, there is considerable impetus to ensure they are measured accurately.

The invetigator's study aims to compare the use of standard pen torch versus quantitative pupillometer for pupil assessment in severely brain injured patients in NCCU. This data could establish whether currently practised pen torch assessment is inadequate for clinical practice. The investigators also propose to study whether pupil response (NPi) changes with rising ICP. This group of patients have invasive monitoring in place as standard care and provides an important opportunity to study this relationship. This has the potential to allow early, non-invasive detection of neurological deterioration and as such, indication for timely intervention in the first instance. It also allows scope for development of this tool across emergency departments and even pre-hospital care settings.

The primary aims of this study are twofold. First, to compare the accuracy and reliability of the pupillometer device (NPi 200) versus the conventional pen-torch technique in measuring pupil response in patients with severe TBI in NCCU.

研究设计

研究类型
Observational
观察模型
Case Only
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
否

入选标准

  • •Patients with severe TBI only aged 18 years or older
  • •At least one reactive pupil on admission
  • •Validated and sedated in induced coma in the Neuro Critical Care Unit

排除标准

  • •Patients with a direct eye trauma, as well as any with a medical history that could impact the relevance of eye examination (opalescent cataract, iris surgery, blindness, third intracranial nerve direct damage) will be excluded.
  • •Patients with irreversible signs of coma at admission (bilateral and nonreactive dilated pupils) will be excluded.
  • •Patients receiving drugs such as barbiturates, that are known to alter pupil reactivity, will be recorded but excluded from ICP association data.

结局指标

主要结局

Hourly Pupil response

时间窗: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers

Hourly NPi Value and corresponding ICP value

时间窗: Recorded hourly from when patient is admitted to Walton Critical Care Unit (CCU) and is undergoing ICP monitoring in situ. Collection of outcome measure will end once ICP monitors are removed; this normally occurs after 7-10 days unless patients recovers

次要结局

未报告次要终点

研究者

发起方
Walton Centre NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

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