Hypercapnia During Thoracoscopy or Open Surgery for Repair of Oesophageal Atresia With Tracheo-oesophageal Fistula or Congenital Diaphragmatic Hernia in Neonates: Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Arterial blood carbon dioxide measurement
研究概览
简要总结
This is a pilot randomised controlled trial comparing open versus thoracoscopic surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates. Thoracoscopic surgery involves insufflation of carbon dioxide into the thoracic cavity and may therefore cause hypercapnia and acidosis.
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
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with diagnosis of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia
- •Conventional ventilation (no high frequency ventilation or iNO) for at least 24 hours.
- •FiO2 <0.4
- •No requirement for inotropes for at least 24 hours
排除标准
- •Late diagnosis (after 1 month of age)
- •Major congenital heart defects or pulmonary hypertension
- •Bilateral grade IV intraventricular haemorrhage
- •Previous ECMO
- •FiO2 ≥ 0.4
研究组 & 干预措施
Hypercapnia during thoracoscopy
keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
干预措施: Hypercapnia during thoracoscopy (Procedure)
Open surgery
open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
干预措施: Open surgery (Procedure)
结局指标
主要结局
Arterial blood carbon dioxide measurement
时间窗: Intra-operative
Arterial blood carbon dioxide will be measured during operation as standard of practice by obtaining the blood samples
次要结局
- oxygenation of the brain(Intra-operative and 24 hours post-operatively)