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临床试验/CTRI/2025/10/096479
CTRI/2025/10/096479尚未招募不适用

Comparison of Perioperative Changes in Optic Nerve Sheath Diameter and their Impact on Neurological Outcomes in Patients Undergoing Decompressive Craniectomy for Traumatic Brain Injury – A Prospective Observational Study

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年11月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
试验地点
1
主要终点
To evaluate the degree of changes in optic nerve sheath diameter perioperatively in patients undergoing decompressive craniectomy for traumatic brain injury.

研究概览

简要总结

This study is about checking the size of optic nerve sheath diameter which is considered an indirect and almost accurate measurement of intracranial pressure before and after emergency decompressive craniectomy for traumatic brain injury patients. As we know traumatic brain injury is a global health burden and the deleterious effects of traumatic brain injury is due to raised intracranial pressure and decompressive craniectomy is a third tier and highest level of treatment of raised intracranial pressure. The perioperative trend of intracranial pressure and it’s supposedly return to normalcy by using non invasive techniques like optic nerve sheath diameter which is a bedside tool and be used to see how it affect the neurological outcomes in those patients. Expecting significant reduction in optic nerve sheath diameter values post decompressive craniectomy implies a reduction in intracranial pressure and hence should be associated with a better neurological outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged 18 to 65 years Isolated traumatic brain injury.

排除标准

  • Patients with orbital injury.Preoperative disorders such as neoplasms, inflammatory disorders of eye, graves disease, and extrinsic compression of optic nerve will be excluded.
  • Patients undergoing bifrontal decompressive craniectomy.
  • Polytrauma.
  • Pregnant patients.
  • Hemodynamic instability.Refusal to consent.

结局指标

主要结局

To evaluate the degree of changes in optic nerve sheath diameter perioperatively in patients undergoing decompressive craniectomy for traumatic brain injury.

时间窗: Immediate preoperative,end operative, post operative 6hours, 12 hours, and 24 hours.

次要结局

  • To evaluate correlation between perioperative optic nerve sheath diameter and neurological outcomes of traumatic brain injury.(To evaluate the perioperative change in optic nerve sheath diameter based on laterality of injury/side of Decompressive craniectomy.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prasanna Udupi Bidkar

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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