NCT05275283Unknown不适用
Efficacy Evaluation of Positive End-expiratory Pressure in Children Undergoing Mechanical Ventilation Using Supraglottic Airway Device
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Respiratory system compliance
研究概览
简要总结
The aim of this study is to determine whether application of positive end-expiratory pressure (PEEP) improves respiratory data including respiratory compliance in children who receive positive pressure ventilation using supraglottic airway device (SAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients under 6 years of age who are scheduled simple operation under general anesthesia
- •SAD was used for mechanical ventilation
排除标准
- •Abdominal distension, risk of pulmonary aspiration
- •Bronchopulmonary dysplasia/respiratory distress syndrome
- •Pneumothorax
- •Airway surgery
- •Thoracic surgery or laparotomy
- •Surgery under prone position
研究组 & 干预措施
Control group
No Intervention
Applying tidal volume 7 ml/kg without PEEP
PEEP group
Experimental
Applying tidal volume 7 ml/kg with 6 cmH2O of PEEP
干预措施: PEEP (Other)
结局指标
主要结局
Respiratory system compliance
时间窗: at the end of surgery, about 2 hours after starting of mechanical ventilation
total lung and chest wall compliance, ml/cmH2O
次要结局
- Respiratory system compliance(10 minutes, 30 minutes, 60 minutes after starting of mechanical ventilation)
- oropharyngeal leak pressure(immediate after SAD insertion)
- Electrical impedance tomography parameter - dynamic compliance(throughout anesthesia (about during 1-3 hours))
- Electrical impedance tomography parameter - regional ventilation delay(throughout anesthesia (about during 1-3 hours))
- Electrical impedance tomography parameter - pulmonary opening pressure(throughout anesthesia (about during 1-3 hours))
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital
研究点 (1)
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