Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Measure of the optic nerve sheath diameter during surgery.
研究概览
简要总结
Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault. In addition, intracranial hypertension measured with invasive methods has been described in certain phases of LT, especially at the time of reperfusion.
The invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients ≥ 18 years
- •Patients who underwent orthotopic liver transplantation
- •Patients who have received clear information and not opposed to participate in the study
- •Patients affiliated to a social security scheme or similar
- •Patients not undergoing a measure of legal protection
排除标准
- •Opposition to participation in the study
- •Patients < 18 years
- •Pregnant women or breastfeeding
- •Deprived of individual liberty
- •Non-affiliated to a social security scheme
- •Known ophthalmic pathology: untreated cataracts, glaucoma
研究组 & 干预措施
Patients undergoing liver transplantation
干预措施: Ultrasound (Device)
结局指标
主要结局
Measure of the optic nerve sheath diameter during surgery.
时间窗: at declamping + 30 min
A value of the optic nerve sheath diameter (averaged over 2 measures) greater than 5.7 mm will be considered pathological, indicating the strong likelihood of intracranial hypertension (PPV near 100% for an intracranial pressure \> 25 cmh2o in the literature) The optic nerve sheath diameter will be measured by ultrasonography, in accordance with existing protocols: Use probe 7.5 Mhz in 2D mode, patient supine dorsi, implementation of ultrasound gel on the closed eyelid, search for the optimal window 3mm, optic nerve sheath diameter measurement behind the retina using an electronic cursor along an axis perpendicular to the optic nerve. 2 measurements per side (sagittal and transverse plane) averaged. Values\> 5.7mm are deemed pathological.
次要结局
- Measurement of intracranial hypertension with transcranial Doppler(at 5 days after surgery.)
- Measurement of intracranial hypertension with transcranial Doppler during surgery.(at declamping + 30 min)
- Measure of the optic nerve sheath diameter after surgery.(at 5 days after surgery.)
- The early appearance of neurological complications after surgery.(During the 5 days following surgery)