The Influence of Lung Protective Ventilation During Pulmonary Lobectomy on Clinical Outcome in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The number 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 pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.
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
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are scheduled for lung lobectomy under general anesthesia
- •ASA physical status I, II
排除标准
- •History of airway or pulmonary interstitial disease
- •Active URI
- •Systemic inflammatory response disease
- •cardiac disease
研究组 & 干预措施
Conventional ventilation group
Mechanical ventilation is maintained with tidal volume (TV) of 10 ml/kg without PEEP during two-lung ventilation and TV of 8 ml/kg without PEEP during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection.
干预措施: Conventional ventilation (Procedure)
Lung protective ventilation group
Mechanical ventilation is maintained with tidal volume (TV) of 6 ml/kg with PEEP 6 cmH2O during two-lung ventilation and TV of 4 ml/kg PEEP 6 cmH2O during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection.
干预措施: lung protective ventilation (Procedure)
结局指标
主要结局
The number of patients with pulmonary complication
时间窗: up to postoperative 7 days
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism
次要结局
- The number of patients with extrapulmonary complication(through study completion, an average of 1 year)
- Mean duration of mechanical ventilation(through study completion, an average of 1 year)
- The number of patients with desaturation(During surgery)
- Mean duration of ICU stay(through study completion, an average of 1 year)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital