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临床试验/CTRI/2024/05/067808
CTRI/2024/05/067808已完成不适用

Correlation between Invasive and Non-Invasive techniques of ICP measurements in patients with Hydrocephalus: A Prospective Observational study

Dr Ankur Luthra1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To establish a correlation between combined values of PI, ONSD, NPi with Invasive ICP (Ventricular opening pressure) in hydrocephalus patients undergoing VP Shunt surgeries.

研究概览

简要总结

Hydrocephalus is an active distension of the ventricular system of the brain related to the inadequate passage of CSF from its point of production within the ventricular system to its point of absorption into the systemic circulation. ICP can be defined as the pressure inside the cranial vault and is the pressure exerted by fluids such as cerebrospinal fluid (CSF) inside the skull and on the brain tissue. ICP is measured in millimetres of mercury (mmHg) and at rest, is normally 7–15 mmHg for a supine adult. The gold standard method of ICP measurement is the Intraventricular catheter based system, but its use has been limited because of complications, cost limiting factors and the requirement of trained personnel to insert the catheter. Thus, non-invasive methods of ICP measurements come into focus which includes Optic Nerve Sheath Diameter measurement using an USG, various methods to estimate PI using TCD/TCCD and the calculation of Npi using a pupilometer. Individually these modalities have their fallacies and the correlation of their combined estimations have not been reliably assessed so far. In our designed study, we will be focusing on mainly ONSD, (PI)Pulsatility index measured by TCD and NPi- Neurological Pupillary index (measured by pupillometer) and their correlations among themselves and with ventricular opening pressure (Invasive intraventricular ICP measurement). We hypothesize that the Combined measurement of PI, ONSD and Npi will have the best correlation with Invasive ICP (Ventricular opening pressure), and it can be used to estimate ICP in hydrocephalus patients with reliable accuracy.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with proven hydrocephalus on CT Scan undergoing VP Shunt surgery.

排除标准

  • Refusal to consent, orbital tumours, iridodialysis, glaucoma and orbital trauma.

结局指标

主要结局

To establish a correlation between combined values of PI, ONSD, NPi with Invasive ICP (Ventricular opening pressure) in hydrocephalus patients undergoing VP Shunt surgeries.

时间窗: At 8 weeks post recruitment of all patients

次要结局

  • 1. To establish the correlation between the following clusters – PI & ONSD vs Opening pressure, ONSD, NPi vs Opening pressure & NPi & PI vs Opening pressure.(At 8 weeks post recruitment of all the patients)
  • 2. To define optimal ONSD, PI & NPi cutoff values for the prediction of intracranial Hypertension(At 8 weeks post recruitment of all the patients)
  • 3. To compare the predictive values of these non-invasive techniques in isolation.(At 8 weeks, post recruitment of all the patients.)
  • 4. To develop a regression equation between ICP, ONSD, PI & Npi for age specific groups to calculate ICP with non-invasive modalities.(At 8 weeks post recruitment of all the patients)

研究者

发起方
Dr Ankur Luthra
申办方类型
Other [Chief Guide]
责任方
Principal Investigator
主要研究者

Vaibhav Pandey

PGIMER, Chandigarh

研究点 (1)

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