NCT03174743Unknown不适用
The Effect of Protective Ventilation During Pulmonary Lobectomy
Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年6月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The proportion of patients with pulmonary complication
研究概览
简要总结
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.
详细描述
The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •1.20 Years and older 2.Patients undergoing pulmonary lobectomy
排除标准
- •Emergency surgery
- •Pulmonary hypertension
- •Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
- •Coagulation disorder
- •Pulmonary or extrapulmonary infections
- •History of treatment with steroid in 3 months before surgery
- •History of recurrent pneumothorax
- •History of lung resection surgery
结局指标
主要结局
The proportion of patients with pulmonary complication
时间窗: up to postoperative 3days
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.
次要结局
- IL6(10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
- IL10(10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
- PaO2 /FiO2(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)
- respiratory compliance(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
Su Liu
Principal Investigator
Xuzhou Medical University
研究点 (1)
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