The Optimal Settings of MI-E in Children With NMD and Weak Cough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- PCF in the MI-E circuit
研究概览
简要总结
Neuromuscular diseases (NMD) in children are severe, possibly life-threatening orphan conditions. The children are vulnerable and often subject to rapid deterioration of pulmonary function due to impaired ability to clear airway secretions. The use of mechanical cough augmentation with insufflation-exsufflation (MIE) is a strategy to treat and prevent. Possible major benefits are described, but optimal settings for best efficacy and comfort in children are not established. The project aim to improve the quality of the treatment with MIE in children with NMD and weak cough. On the basis of a bench study a clinical trial aims to examine the most effective MIE settings when used in stable state and when respiratory tract infections are present.
详细描述
On the basis of a prevalence study and a bench study different settings will be studied in children with NMD and weak cough to examine if settings derived from the lung model, are optimal to increase the peak cough flow (PCF) and comfort measured by visual analogue scale (VAS) in children with NMD and weak cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant, care provider, investigator and outcomes assessor are blinded from the order of the settings tested. Only a technician change settings and know the order.
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed neuromuscular disease < 18 years
- •Established use (> 3mnd) of MI-E.
- •Reduced PCF
- •PCF < 270 l/min (when > 12 years)
- •< 5th percentiles for PCF 16 (when 4 - 12 years)
- •Clinical indication (difficulty to clear secretions, audible weak cough, history of pneumonia or frequent or prolonged respiratory tract infections).
排除标准
- •age < 6 mnd
- •obstructive lung disease (hyperinflation or emphysema on x-ray.
研究组 & 干预措施
MI-E testing symmetric settings
Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
干预措施: Symmetric settings (high pressures/fast rate) (Other)
MI-E testing symmetric settings
Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
干预措施: Asymmetric settings (Pi<Pe/Ti>Te) (Other)
MI-E testing symmetric settings
Symmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
干预措施: Preinclusion settings (Other)
MI-E testing assymetric settings
Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
干预措施: Symmetric settings (high pressures/fast rate) (Other)
MI-E testing assymetric settings
Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
干预措施: Asymmetric settings (Pi<Pe/Ti>Te) (Other)
MI-E testing assymetric settings
Asymmetric settings is one of 3 different settings that will be tested on the same day but in randomized order.
干预措施: Preinclusion settings (Other)
Settings in use
Settings in use is one of 3 different settings that will be tested on the same day but in randomized order
干预措施: Symmetric settings (high pressures/fast rate) (Other)
Settings in use
Settings in use is one of 3 different settings that will be tested on the same day but in randomized order
干预措施: Asymmetric settings (Pi<Pe/Ti>Te) (Other)
Settings in use
Settings in use is one of 3 different settings that will be tested on the same day but in randomized order
干预措施: Preinclusion settings (Other)
结局指标
主要结局
PCF in the MI-E circuit
时间窗: 30 minutes.
Recording of maximal value produced by the MI-E device during Cough
Patient reported comfort
时间窗: Total time use 30 min
Comfort rated on a Visual Analog Scale (VAS) (0-100) where 100 is very uncomfortable and 0 is very comfortable.
次要结局
- Oxygen(maximal time use is 30 min)
- Hart rate(Total max 30 minutes (During three MI-E trials))
- Carbon dioxide(maximal time use is 30 min)
- Patient reported efficacy(The VAS is recorded after each of the three trials. Total time use 30 min)
研究者
Brit Hov
Physiotherapist
Oslo University Hospital