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临床试验/NCT01540201
NCT01540201已完成不适用

The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2012年2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
110
试验地点
2
主要终点
arterial CO2 partial pressure

研究概览

简要总结

Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with lung protective strategy.

详细描述

Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. Continuous positive airway pressure or positive end-expiratory pressure are usually applied to improve this disorder including hypoxia, but these methods are not enough. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. The application of IRV during OLV has not been performed to our knowledge, and there is a possibility of IRV to improve oxygenation during OLV. There is a possibility of increase of auto-PEEP, or air trapping in subjects with chronic obstructive pulmonary disease, but this kind of auto-PEEP can be overcome by external PEEP. Therefore, we tried to evaluate the effect of IRV during OLV with lung protective strategy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • patients undergoing elective lung lobectomy surgery.
  • the duration of one-lung ventilation is more than one hour.
  • subjects with more than twenty years old.

排除标准

  • subjects with past history of pneumothorax, asthma
  • Age under 20, more than 70 years.
  • Patients with ischemic heart disease, valvular heart disease
  • patients with hemodynamic unstability

结局指标

主要结局

arterial CO2 partial pressure

时间窗: 1 hour after the end of surgery

arteial CO2 partial pressure

次要结局

  • arterial O2 partial pressure(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery)
  • Mean airway pressure(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • tidal volume (exhaled)(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • hemodynamic parameters(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • end-tidal CO2 partial pressure(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • respiratory compliance(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • Dead space(10 min after induction, 30 and 60 min after start of one lung ventilation, 15 min after restart of two-lung ventilation)
  • work of breathing(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • plateau pressure(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • positive end-expiratory pressure(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • minute ventilation(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
  • peak inspiratory pressure(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)

研究者

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

Sangmin M. Lee

Professor

Samsung Medical Center

研究点 (2)

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