'Fitness To Fly' Testing In Children With Neuromuscular Weakness Or Central Hypoventilation: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- proof of concept outcome 1
研究概览
简要总结
The conventional hypoxic challenge test might not predict 'fitness-to-fly' equally well in all patients. Patients at risk of hypercapnia with supplemental oxygen are not well studied. Th investigators will study children who have either neuromuscular weakness or central hypoventilation and who require nocturnal or intermittent daytime ventilator support.
The study also aims to assess feasibility of a randomised controlled trial (RCT) comparing the standard hypoxic standard test to a modified test designed to better suit children with type two respiratory failure.
详细描述
This study will assess feasibility of pulse oximetry (SpO2), end tidal carbon dioxide (ETCO2) and transcutaneous carbon dioxide partial pressure (TcCO2) measurement during a modified Hypoxic challenge test (HCT) in 12 children with neuromuscular weakness and 12 with central hypoventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤18 years
- •Neuromuscular weakness or central hypoventilation
- •Established nocturnal or intermittent daytime ventilatory support
排除标准
- •Unable to sit in the plethysmograph
- •Cardiac anomaly with right-to-left shunt
结局指标
主要结局
proof of concept outcome 1
时间窗: during hypoxic challenge test
number of children/infants with SpO2 \<90/85%
proof of concept outcome 2
时间窗: during hypoxic challenge test
number of children with \>15 mmHg rise in TcCO2/EtCO2
次要结局
- Feasibility outcome 1: recruitment rate(one year)
- Feasibility outcome 2: protocol completion rate(one year)