跳至主要内容
临床试验/NCT01864499
NCT01864499已完成不适用

Perioperative Evaluation of Intracranial Hypertension by Ultrasound Measurement of Variations in the Diameter of the Sheath of the Optic Nerve in the Excision of a Tumor or Biopsy Supratentorial Brain

Poitiers University Hospital0 个研究点开始时间: 2013年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
主要终点
Difference in mean changes that the sheath of postoperative optic nerve

研究概览

简要总结

Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound.

The evaluation of intracranial pressure by measuring the DNO in perioperative is not described in the literature. The investigators propose a pilot study to assess intracranial pressure perioperative surgery for supratentorial brain tumor. The investigators consider a diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal healthy adult unanesthetized is 5 mm.

The main objective of the study is to compare the mean change in diameter of the optic nerve between the postoperative and D2 between groups of patients undergoing resection of a brain tumor and patients undergoing biopsy brain tumor.

Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients is estimated according to the recruiting capabilities of neurosurgery for this type of patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control group: 20 patients Biopsy Brain Tumor.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Hospitalized for surgery of intracerebral tumors in the study group.
  • Hospitalized for a biopsy of intracerebral tumor lesion in the control group.

排除标准

  • Age <18 years
  • Enucleation Prohibited to the achievement of an ocular ultrasound
  • Hypersensitivity to gel
  • Eye Wound
  • Massive facial fracture
  • Skin Infection Site

结局指标

主要结局

Difference in mean changes that the sheath of postoperative optic nerve

时间窗: 2 days

Difference in mean changes that the sheath of postoperative optic nerve and J2 between groups of patients undergoing resection of brain tumor patients undergoing biopsy for brain tumor

次要结局

  • Difference in diameter of the sheath of the pre-and postoperative optic nerve(5 days)

研究者

申办方类型
Other
责任方
Sponsor

相似试验