The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG).
研究概览
简要总结
There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations
- •lives within the greater Toronto area.
排除标准
- •known diagnosis of nocturnal hypoventilation
- •current ventilatory support
- •physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).
结局指标
主要结局
Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG).
时间窗: 9 months
次要结局
- a) Agreement of tcCO2 monitoring when worn in the ambulatory, at home, setting compared to tcCO2 recorded during a PSG in a hospital based sleep laboratory for diagnosis of nocturnal hypoventilation.(9 months)
研究者
Reshma Amin
Staff Physician
The Hospital for Sick Children