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临床试验/CTRI/2026/04/108226
CTRI/2026/04/108226尚未招募不适用

Utility of automated infrared pupillometry and Optic Nerve Sheath Diameter and as Initial Screening Tools in Severe Traumatic Brain Injury

Grant Medical Foundation Ruby Hall Clinic1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年4月23日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
ICU stay duration

研究概览

简要总结

  • Clinical need - Decisions to escalate beyond Seattle International Severe Traumatic Brain Injury

Consensus Conference SIBICC tier-0 carry major implications sedation hyperosmolar therapy ICP

monitoring and decompressive surgery. As a screening tool at admission can prioritize monitoring beds and

early interventions

-  ORANGE study establishes NPi as a dynamic outcome predictor in acute brain injury—justifying NPi

as admission screen [4]

  • Ultrasound ONSD not only is a non-invasive and easy to do, quick procedure but also improves feasibility

  • To date no study has rigorously evaluated NPi + ONSD at admission to predict INCC (rather than ICP

alone or long-term outcome). Demonstrating that NPi less than 3 and or ONSD abnormal yields a low negative

likelihood ratio for requirement for intensive neurocritical care would provide a practical, non-invasive

rule-out bundle for early triage.

  • Both AIP and ONSD can be completed within minutes of ICU arrival, prior to osmotherapy or deep

sedation, enabling early classification and potential protocolization across centres with varied

neuromonitoring capacity.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •1 Severe head trauma 2 Prehospital GCS less than 9 3 Intracranial lesion identified on initial CT head.

排除标准

  • •1 Penetrating Head Injury 2 Bilateral ocular trauma or eyelid injury precluding pupillometry or ONSD 3 Prior enrolment in the study 4 Pre existing ocular disease significantly distorting ONSD or pupillary anatomy.

结局指标

主要结局

ICU stay duration

时间窗: 72 hours

In-hospital mortality

时间窗: 72 hours

Neurosurgical Intervention

时间窗: 72 hours

次要结局

未报告次要终点

研究者

发起方
Grant Medical Foundation Ruby Hall Clinic
申办方类型
Other [Trust Hospital]
责任方
Principal Investigator
主要研究者

Dr Anand Tiwari

Grant Medical Foundation Ruby Hall Clinic

研究点 (1)

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