Comparison of the Inflammatory Response After One-lung Ventilation With Positive Ventilation and Self-respiration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Interleukin (IL)-6
研究概览
简要总结
Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated 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
- 否
入选标准
- •elective video-assisted thoracoscopic surgery (VATS) lobectomy
- •20 < age < 75
- •American Society of Anesthesiologists (ASA) classification I~II
排除标准
- •preoperative inflammation (CRP>10ng/㎖, WBC>10,000/mm3, body temperature >38℃)
- •steroid administration within 1 month
- •hematologic / autoimmune disease
- •congestive heart failure (NYHA class III~IV) or significant arrhythmia
- •severe obstructive / restrictive pulmonary disease
- •previous history of thoracic surgery
- •BMI >28kg/m2
- •expected difficult airway
研究组 & 干预措施
Non-intubated
The patients were oxygenated via facial mask with O2 5~10 L/min during the whole procedure. The end-tidal carbon dioxide (EtCO2) was measured by insertion of a detector inside one of the nostrils. Respiration rate was maintained between 12 and 20 breaths/min with adjustment of anesthetics.
干预措施: Ventilation method (Other)
Intubated
The patient was intubated with a left-sided double-lumen endobronchial tube. The protective ventilation was performed as follows: a tidal volume of 6 mL/kg predicted body weight, I:E ratio of 1:2, a respiratory rate to maintain PaCO2 within 35 to 45 mmHg, and positive end-expiratory pressure at 5 cmH2O. If the airway pressure exceeded 25 cmH2O, tidal volume was adjusted.
结局指标
主要结局
Interleukin (IL)-6
时间窗: 24 hours after surgery
Blood samples collected from the antecubital vein
次要结局
未报告次要终点
研究者
Wonjung Hwang
Assistant professor
Seoul St. Mary's Hospital