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
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
- 是
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