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临床试验/NCT01379313
NCT01379313已完成不适用

The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
arterial CO2 partial pressure

研究概览

简要总结

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

详细描述

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective gynecologic laparoscopic surgery
  • the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes

排除标准

  • ASA (American society of anesthesiologists) classification of the subjects more than III.
  • Age under 20, or more than 65 years.
  • Past history of pneumothorax, COPD, asthma.
  • Patients with ischemic heart disease, valvular heart disease.

结局指标

主要结局

arterial CO2 partial pressure

时间窗: 60 minutes after start of pneumoperitoneum

arteial CO2 partial pressure

次要结局

  • Mean airway pressure(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • arterial O2 partial pressure(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • tidal volume (setting)(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • hemodynamic parameters(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • end-tidal CO2 partial pressure(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • respiratory compliance(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • Dead space(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • work of breathing(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • peak inspiratory pressure(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • plateau pressure(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • positive end-expiratory pressure(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • tidal volume (exhaled)(10 min after induction, 30 and 60 min after start of pneumoperitoneum)
  • minute ventilation(10 min after induction, 30 and 60 min after start of pneumoperitoneum)

研究者

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

Tae Soo Hahm

Professor

Samsung Medical Center

研究点 (2)

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