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临床试验/NCT04583046
NCT04583046已完成不适用

Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation

Yonsei University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年11月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)

研究概览

简要总结

One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for VATS lobectomy
  • 40 < age < 80
  • American Society of Anaesthesiologists(ASA) physical status classification I~III
  • BMI > 30 kg /m2

排除标准

  • American Society of Anaesthesiologists(ASA) physical status classification IV or more
  • NYHA class III~IV
  • Severe obstructive lung disease and/or restrictive lung disease patients
  • patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
  • pregnant women
  • pulmonary edema or pulmonary arterial hypertension
  • cerebrovascular disease
  • unstable angina or myocardial infarction within 6 months
  • patients with allergic reaction at iloprost

研究组 & 干预措施

placebo

Placebo Comparator

normal saline inhalation group

干预措施: normal saline inhalation (Drug)

iloprost group

Experimental

iloprost inhalation group

干预措施: iloprost inhalation (Drug)

结局指标

主要结局

Result of arterial blood gas analysis : partial pressure of oxygen(PaO2)

时间窗: 20 minutes after iloprost inhalation (T2)

Result of arterial blood gas analysis : partial pressure of oxygen in the arterial blood(PaO2)/Fraction of inspired oxygen(FiO2) ratio (P/F ratio)

时间窗: 20 minutes after iloprost inhalation (T2)

Result of arterial blood gas analysis : Oxygen saturation in arterial blood(SaO2)

时间窗: 20 minutes after iloprost inhalation (T2)

次要结局

  • deadspace(20 minutes after iloprost inhalation (T2))
  • intrapulmonary shunt(20 minutes after iloprost inhalation (T2))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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