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临床试验/NCT03936140
NCT03936140已完成不适用

The Effect of Iloprost on Arterial Oxygenation and Shunt Fraction During One-lung Ventilation for Lung Surgery

Seoul St. Mary's Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年1月4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
72
试验地点
1
主要终点
PaO2(partial pressure of arterial oxygen)

研究概览

简要总结

During one-lung ventilation in patients undergoing thoracic surgery, the persistent flow in the non-ventilated lung increases intrapulmonary shunt and decreases systemic arterial oxygenation. This prospective, randomized, double blind study was conducted to evaluate the effects of inhaled iloprost during one-lung ventilation on arterial oxygenation and shunt fraction during thoracic surgery.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective video-assisted thoracoscopic surgery (VATS) lobectomy
  • 20 < age < 75
  • American Society of Anesthesiologists (ASA) classification I~III

排除标准

  • ASA classification IV
  • New York Heart Association (NYHA) class III~IV
  • Severe obstructive lung disease / restrictive lung disease
  • Pulmonary hypertension
  • End-stage organ disease (i.e. hepatic failure, renal failure)
  • Arrhythmia
  • Previous history of thoracic surgery

研究组 & 干预措施

Iloprost 10

Experimental

Iloprost 10μg of inhaled iloprost (Ventavis®)

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

干预措施: Inhaled iloprost (Drug)

Iloprost 20

Experimental

Iloprost 20μg of inhaled iloprost (Ventavis®)

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

干预措施: Inhaled iloprost (Drug)

Distilled water

Placebo Comparator

Distilled water

Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.

干预措施: Distilled water (Drug)

结局指标

主要结局

PaO2(partial pressure of arterial oxygen)

时间窗: 30 min after treatment

ABGA

Pulmonary shunt fraction

时间窗: 30 min after treatment

Qs/Qt = (CcO2-CaO2) / (CcO2-CvO2)

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

Wonjung Hwang

Assistant professor

Seoul St. Mary's Hospital

研究点 (1)

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