跳至主要内容
临床试验/NCT04849221
NCT04849221已完成不适用

Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Volume of the ear canal as a function of intracranial pressure

研究概览

简要总结

Intracranial pressure is usually measured by invasive methods requiring an intracranial sensor. There is no non-invasive monitoring method recognized as a gold standard. Tympanometry would make it feasible to evaluate intracranial pressure through sensitive and specific changes in the energy absorbance of the middle ear. It could represent a non-invasive method of monitoring intracranial pressure.

This is a prospective monocentric longitudinal study. All adult patients in intensive care for head trauma, intracranial hypertension, or after cranial surgery and requiring invasive monitoring of ICP will be included after their non-opposition has been collected.

In a group of 10 controls, multifrequency tympanometry will be performed in the standing position, in the 0° supine position and in the Tredelenburg position at -17°.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Person who did not oppose to their inclusion in the trial
  • Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke...) requiring monitoring of ICP by a subdural or epidural sensor.
  • Age > 18 years old
  • Person who did not oppose to their inclusion in the trial
  • Age > 18 years old
  • No otologic or neurological history.

排除标准

  • Person subject to a measure of legal protection (curatorship, guardianship)
  • Person under judicial control
  • Pregnant, parturient or breastfeeding woman
  • Fracture of the petrosal bone, abnormality of the bilateral middle or inner ear or canal preventing tympanometry

结局指标

主要结局

Volume of the ear canal as a function of intracranial pressure

时间窗: Approximately on the 10th day

Middle ear resonance frequency as a function of intracranial pressure

时间窗: Approximately on the 10th day

Width between conductance peaks of tympanometry at 2kHz as a function of intracranial pressure

时间窗: Approximately on the 10th day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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