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临床试验/CTRI/2021/03/031613
CTRI/2021/03/031613尚未招募不适用

Ultrasonic measurement of optic nerve sheath diameter in prolonged abdominal surgery (UMONDStudy).

Department of Anaesthesia Critical Care and Pain1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月3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
200
试验地点
1
主要终点
Perioperative variation of optic nerve sheath diameter

研究概览

简要总结

•Prolonged abdominal surgery incurs large amount of blood loss, rapid fluid replacement and fluid shifts across physiological barriers causing tissue edema and raised ICP.

•Added conditions such as- pneumoperitonium, trendelenberg position increase ICP further.

•Raised ICP is reflected in Optic nerve sheath diameter (ONSD) as the ON is surrounded by dural sheath and increased CSF pressure causes the sheath to swell.

ONSD measured at 3 mm below the optic disc using a high frequency linear ultrasound transducer (UST) is

•Safe, reliable, >90% accuracy

•Can be performed by any anaesthesiologist with some training in point of care ultrasound (POCUS).

The primary objective of the study is to develop a model which can predict the change in ONSD after surgery based on various clinical and intraoperative parameters. We will model the difference in OND using a linear regression model with prespecified parameters, mainly-

1.Prolonged duration

2.Trendelenberg position (head down)

3.Pneumoperitonium (laparoscopy)

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Abdominal surgery lasting for more than 4 hours.

排除标准

  • Known retinal disease Known optic disease.

结局指标

主要结局

Perioperative variation of optic nerve sheath diameter

时间窗: Measurement of optic nerve sheath diameter preoperatively and postoperatively before extubation/ in ICU in case if Patient is shifted intubated to icu

次要结局

  • Conjunctival edema associated? yes/ no(before and at the end of surgery)

研究者

发起方
Department of Anaesthesia Critical Care and Pain
申办方类型
Research institution and hospital

研究点 (1)

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