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临床试验/NCT03031613
NCT03031613Unknown不适用

Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2017年1月最近更新:
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
IOP

研究概览

简要总结

To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)

详细描述

Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients undergoing robotic-assisted laparoscopic radical prostatectomy

排除标准

  • History of opthalmic disease or surgery
  • History of brain disease or surgery
  • Known ICP elevation
  • Known IOP elevation
  • Presence of lung bullae on chest x-ray
  • History of pneumothorax

结局指标

主要结局

IOP

时间窗: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min

IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®

ICP

时间窗: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min

ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound

次要结局

未报告次要终点

研究者

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

Dong Woo Han

Professor

Gangnam Severance Hospital

研究点 (2)

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