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临床试验/NCT02071550
NCT02071550已完成不适用

10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices

Turkiye Yuksek Ihtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
change in cerebral oxymetry during laparoscopy

研究概览

简要总结

In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).

Methods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA(American Society of Anesthesiologist) class I and II
  • Patients undergoing laparoscopic cholecystectomy

排除标准

  • ASA class III and IV
  • Morbid obesity
  • Emergency cases
  • Cases returned to laparotomy

结局指标

主要结局

change in cerebral oxymetry during laparoscopy

时间窗: 1 day

次要结局

未报告次要终点

研究者

发起方
Turkiye Yuksek Ihtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

aslı demir

Associated professor

Turkiye Yuksek Ihtisas Education and Research Hospital

研究点 (1)

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