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临床试验/CTRI/2024/03/063603
CTRI/2024/03/063603进行中(未招募)不适用

Correlation of Optic Nerve Sheath Diameter with External Ventricular Drain for measurement of Intracranial Pressure : An Observational Study

Institute of Neurosciences Kolkata1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年3月10日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
48
试验地点
1
主要终点
Optic nerve sheath diameter(ONSD)

研究概览

简要总结

After getting institutional ethics committee  approval, CTRI no. and written consent of

patient’s nearest of kin, patients will be included in this study.The demographic data (age ,gender,

race),Glasgow Coma Score(GCS),pupillary size and reactions, vital signs(heart rate ,respiratory

rate,blood pressure,temperature) and CT scan findings will be recorded on admission to ITU. The

verbal score of GCS will be modified for intubated patients using the formula: Derived Verbal

Score=−0.3756+Motor Score×(0.5713)+Eye Score×(0.4233)[17].All patients will be sedated with

midazolam and fentanyl administered intravenously, according to the treating physician’s

discretion. Following the decision to place an ICP monitoring device (EVD) (by the attending

intensive care physician and neurosurgeon), the patients will be enrolled in this study.Ocular US

will be conducted with SonoSite Micromax (SonoSite Inc., Bothell, WA, USA) ultrasonography

(USG) machine. Each patient will be examined in the supine position using a linear USG probe of

10-5 MHz frequency to get ONSD at 3 mm posterior to the ocular globe. The probe will be applied

on the temporal part of the closed upper eyelid with coupling gel [18] [19]. For each patient,

investigator will perform two measurements on each eye in transverse plane. The resulting four

measurements will then be averaged to yield a mean ONSD to minimise intraobserver variability.

Initial US ONSD will be measured before placement of the EVD catheter. The opening pressure

after placement of the EVD catheter, will be used as the initial ICP, and Intracranial hypertension

will be considered present when the patient will be having ICP above 20 mmHg for a period of

time greater than 5 min.The investigator measuring the ONSD with ultrasonography will be

blinded to invasive measurements of ICP. The need for urgent life saving surgery i.e.

Decompressive Craniectomy will also be noted.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)

入选标准

  • Adult patients (aged ≥18 years)
  • Either Gender
  • Isolated Brain injury
  • Patients requiring EVD.

排除标准

  • Adult patients (aged ≥18 years)
  • Either Gender
  • Isolated Brain injury
  • Patients requiring EVD.

结局指标

主要结局

Optic nerve sheath diameter(ONSD)

时间窗: At baseline

次要结局

  • Decompressive craniectomy(At 5 mins from 0 hours)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Ismail Shahidullah

Institute of Neurosciences, Kolkata

研究点 (1)

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