Effects of Iloprost on Oxygenation During One-lung Ventilation in Supine-positioned Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
研究概览
简要总结
One-lung ventilation (OLV) is essential during mediastinal mass excision. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung. In addition, it is reported that supine positioning of patient during OLV, which is required during mediastinal mass excision, results in worse oxygenation than lateral decubitus positioning.
Iloprost is a prostaglandin analogue and when inhaled during OLV, it acts selectively on the pulmonary vasculature, reducing pulmonary vascular resistance of well-ventilated lung and thereby alleviating ventilation-perfusion mismatch. The purpose of this study is to evaluate the effects of inhaled iloprost on oxygenation during one-lung ventilation in patients undergoing mediastinal mass excision.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for Video-assisted thoracoscopic surgery (VATS) mediastinal mass excision
- •Patient age from 20 to 80
- •American Society of Anaesthesiologists (ASA) physical status classification II~III
排除标准
- •Chronic obstructive pulmonary disease (COPD) with Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio < 0.7 and percentage of predicted FEV1 ≤ 80%
- •Diffusing capacity of carbon monoxide (DLCO) < 80%
- •Aspartate transaminase (AST) level ≥100 IU/mL or alanine transaminase (ALT) ≥ level 50 IU/L
- •Creatinine clearance ≤ 30mL/min
- •Congestive heart failure, arrhythmia
- •Unstable angina, coronary artery occlusive disease (CAOD), history of myocardial infarction within 6 months
- •Pulmonary edema, pulmonary arterial hypertension
- •Allergic to prostaglandin or prostacyclin analogue
- •Patients with peptic ulcer bleeding, trauma, intracranial hemorrhage
- •History of cerebrovascular disease (e.g. transient ischemic attack, stroke) within 3 months
- •Valvular heart disease
- •Pregnant women
研究组 & 干预措施
Control group
干预措施: 5ml of inhaled normal saline (Drug)
Iloprost group
干预措施: 20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline (Drug)
结局指标
主要结局
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)
时间窗: Twenty minutes after the completion of drug inhalation
The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of iloprost on oxygenation during OLV.
次要结局
未报告次要终点