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临床试验/NCT04188353
NCT04188353已完成不适用

Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter(ONSD) in Patients With Raised Intracranial Pressure

Tribhuvan University Teaching Hospital, Institute Of Medicine.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月24日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration

研究概览

简要总结

Osmotherapy with mannitol has been a common practice in patients with raised ICP. Monitoring its effect on ICP can be performed invasively and non-invasively. Due to a validated correlation between invasive ICP monitoring and ONSD measurement, it can be a tool to monitor acute and long term effects of osmotherapy non-invasively on ICP. This study examines the acute changes in sonographically measured ONSD brought about by the administration of mannitol. This can correlate with the changes in ICP in such patients and can be utilized as a tool for decision making/ point-of-care utility.

详细描述

This is a prospective cohort based observational study including 40 patients admitted in the adult ICU at our center diagnosed as either a case of TBI/ acute stroke/ intracranial hemorrhages with a mean screening ONSD of more than 5mm under mannitol osmotherapy. ONSD were measured by a high frequency linear array probe (>10 Hz) at the time of screening. Mannitol was then administered at doses prescribed by the treating physician over 20-30 minutes via a dedicated intravenous line. ONSDs were measured again at 30, 60 and 120 minutes after completion of administration of mannitol. Demographic data, baseline ventilator parameters of patients on mechanical ventilation, GCS and mean arterial pressure at each time points were recorded. Comparison of variables at these time points were made.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age > 18 years
  • •diagnosed as a case of TBI/ acute stroke/ intracranial hemorrhages
  • •screening mean ONSD > 5 mm
  • •under osmotherapy with mannitol in standard doses (0.25 - 1 gm/kg)

排除标准

  • •baseline ocular pathology like tumors, Graves' disease and sarcoidosis
  • •previous ocular surgery
  • •Decompressive cranial surgery

结局指标

主要结局

optic nerve sheath diameter at 30, 60 and 120 minutes after mannitol administration

时间窗: 30, 60 and 120 minutes

Change in optic nerve sheath diameter (ONSD)

次要结局

  • Correlation between dose and change in ONSD(30, 60 and 120 minutes)
  • Correlation between change in ONSD and Mean arterial pressure(30, 60, and 120 minutes)

研究者

发起方
Tribhuvan University Teaching Hospital, Institute Of Medicine.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shiva Prasad Paudyal

Resident, PGY-III, Anesthesiology

Tribhuvan University Teaching Hospital, Institute Of Medicine.

研究点 (1)

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