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临床试验/NCT07151287
NCT07151287尚未招募不适用

Diagnosis of Intracranial Hypertension Using TCCD, ONSD and ODH by Bedside Ultrasound

Xiangya Hospital of Central South University0 个研究点目标入组 64 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
主要终点
Sensitivity and specificity of TCCD

研究概览

简要总结

The goal of this observational study is to investigate several means of measuring intracranial pressure (ICP) non-invasively in patients who had head trauma and received implantation of invasive ICP monitor device. The main questions it aims to answer are:

What are the diagnostic efficacies of Transcranial Color-Coded Doppler Ultrasound (TCCD), Optic Nerve Sheath Diameter (ONSD) and Optic Disc Height (ODH) (the 3 non-invasive way of measuring ICP) compared with invasive ICP monitor? Participants will receive simultaneous non-invasive measurements of TCCD, ONSD and ODH along with during the days of invasive ICP monitoring. The data will be compared among the techniques to study the diagnostic efficacy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Traumatic brain injury;
  • Received invasive ICP monitoring;
  • age ≥ 18 years old.

排除标准

  • Severe eyeball / eyelid damage prevents transorbital ultrasound examination;
  • Allergy to ultrasound coupling agent;
  • Pregnant or lactating females.

结局指标

主要结局

Sensitivity and specificity of TCCD

时间窗: Day 0 (when invasive ICP probe is implanted) to day 10

Sensitivity and specificity of diagnosing intracranial hypertension using TCCD

Sensitivity and specificity of ONSD

时间窗: Day 0 (when invasive ICP probe is implanted) to day 10

Sensitivity and specificity of diagnosing intracranial hypertension using ONSD

Sensitivity and specificity of ODH

时间窗: Day 0 (when invasive ICP probe is implanted) to day 10

Sensitivity and specificity of diagnosing intracranial hypertension using ODH

次要结局

  • Pearson correlation coefficient between ultrasound metrics and invasive ICP(Day 0 (when invasive ICP probe is implanted) to day 10)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jinfang Liu, MD

Director of the Neurotrauma and Neurointensive Care Group

Xiangya Hospital of Central South University

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