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临床试验/NCT04316208
NCT04316208Unknown不适用

The Effect of Intraoperative Variations in Positive-End Expiratory Pressure on Subdural Pressure, Optic Nerve Sheath Diameter, Lung Compliance and Brain Perfusion Pressure in Supratentorial Tumor Surgery

Istanbul University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Subdural pressure

研究概览

简要总结

We aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize optic nerve sheath diameter measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

详细描述

Application of positive end-expiratory pressure (PEEP) during general anesthesia minimizes ventilation/perfusion mismatch, intraoperative atelectasis and postoperative pulmonary complications. PEEP application in intracranial surgeries is usually avoided due to the risk of raised intracranial pressure (ICP) leading to decreased cerebral perfusion pressure (CPP). Several studies examine the effects of PEEP on subdural pressure and CPP however none examine how lung compliance is affected at the same time. Ultrasound-guided measurement of optic nerve sheath diameter (ONSD) is an indirect indicator of raised ICP and there is limited literature on the correlation of ONSD and ICP during intracranial surgery. In this study, we aim to determine the level of intraoperative PEEP that optimizes lung compliance without causing a rise in subdural pressure and if we can utilize ONSD measurement as an indicator for ICP while optimizing lung compliance during supratentorial tumor surgeries.

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

盲法说明

Care provider will adjust the PEEP level, make measurements and record arterial blood gas analysis results. Biostatistician will compare data set at each PEEP to each other. Investigator will analyze the data

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Supratentorial tumor
  • Elective surgery
  • American Society of Anesthesiologist Class I, II or III

排除标准

  • Midline shift more than 5 mm determined by intracranial imaging
  • Initial subdural pressure higher than 20 mmHg
  • Requiring intravenous mannitol or hypertonic saline treatment before dural opening
  • Congestive heart failure
  • Pulmonary hypertension
  • Hypovolemia
  • Obstructive or restrictive lung disease

结局指标

主要结局

Subdural pressure

时间窗: Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)

22G/ 0.9mm catheter will be introduced into subdural space after craniotomy and connected to the transducer for pressure measurement

Optic nerve sheath diameter (left and right)

时间窗: Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10)

Ultrasound-guided measurement with the linear probe.

次要结局

  • Lung compliance(Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10))
  • Mean arterial pressure(Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10))
  • Brain relaxation index(Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10))
  • Arterial blood gases(Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10))
  • Regional cerebral oxygen saturation(Measurements will look at the change between 3 timepoints: at 5 minutes with PEEP of 0 cmH2O (T0), then at 5 minutes with PEEP of 5 cmH2O (T5), and finally at 5 minutes with PEEP of 10 cmH2O (T10))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Korkmaz Dilmen

Professor in Anesthesiology and Reanimation

Istanbul University

研究点 (2)

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