Effects of Iloprost on Pulmonary Hemodynamics and Oxygenation in Patients of Chronic Obstructive Pulmonary Disease During One-lung Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- PaO2 /FiO2 ratio during one-lung ventilation
研究概览
简要总结
The inhaled Iloprost, approved for pulmonary hypertension, caused increase in oxygenation, and increase exercise tolerance in ARDS or chronic obstructive pulmonary disease. Inhaled iloprost has been researched in animal study, but not yet in human during one-lung ventilation. The investigators will enroll patients who diagnosed moderate to severe chronic obstructive pulmonary disease, preoperative pulse oximetry (SpO2) of below 95% at room air or PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation. The primary outcome is pulmonary oxygenation expressed by PaO2 /FiO2 ratio. And secondary outcome is assessment of cardiac function including Tei-index during nebulizing iloprost. The investigators hypothesized inhaled iloprost will improve oxygenation and decrease the FiO2 in chronic obstructive pulmonary disease during one-lung ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Chronic obstructive pulmonary disease was defined as FEV1/FVC ratio < 0.7 and an FEV 1 of 80% or less after inhalation bronchodilator :
- •Above 40 years of age.
- •American Society of Anesthesiologists (ASA) Physical Status II, III.
- •Preoperative SpO2 95 % or less at room air (spontaneous ventilation) or
- •PaO2 /FiO2 ratio< 150 mmHg after initiating one-lung ventilation
排除标准
- •Severe functional liver or kidney disease
- •Diagnosed HF (LV ejection fraction <50% , or wall motion abnormality)
- •Arrhythmia or received treatment with antiarrythmic drug .
- •Severe bradycardia(HR < 45 bpm) and AV block
- •pathologic esophageal lesion (esophageal stricture or varix )
- •PaO2 /FiO2 ratio ≥ 150 mmHg after initiating one-lung ventilation
研究组 & 干预措施
Iloprost group
干预措施: Inhaled iloprost (Drug)
normal saline
干预措施: normal saline (Saline 0.9%) (Drug)
结局指标
主要结局
PaO2 /FiO2 ratio during one-lung ventilation
时间窗: oxygenation changes from baseline (OLV), in 30 min after nebulizing iloprost or normal saline(ILO-30), in 60 min after nebulizing iloprost or normal saline(ILO-60), to after 20 min in postanaestheticcare unit(PACU)
次要结局
- biventricular diastolic function(biventricular diastolic function changes from baseline(baseline), 60 min after nebulizing iloprost or normal saline (ILO))