Mechanical INsufflator/EXsufflator Technique in Paediatric Subjects With Neuromuscular Disease: a Randomised Crossover Comparison of 2 Modes of Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in end-expiratory lung impedance from baseline
研究概览
简要总结
In a randomized cross-over design, two different modes of a mechanical insufflator/exsufflator applied to pediatric subjects with neuromuscular disease will be compared with respect to their short term effect on lung function, i.e. lung volume.
详细描述
At two consecutive regular outpatient clinic visits, each participant will perform a session of the insufflation/exsufflation technique.
Participants will be randomised by a computer-generated code to one of the two sequences (CON-MOD or MOD-CON) using sealed envelopes. The randomisation list will be generated by a study nurse of the Department of Paediatrics who is not a member of the study group.
The randomisation envelope will be opened by the treating physiotherapist immediately before the first treatment session.
Standardised intervention
At randomisation, the measurement belt of the EIT system will be fitted around the chest of the participant. Once correct fit is confirmed, the baseline measurement (T0) will be taken. After the baseline assessment, the participants will perform the conventional (CON) or modified (MOD) insufflator/exsufflator therapy session under supervision of a physiotherapist. In teh investigator's institution a therapy session consists of 5 series of 5 insufflation/exsufflation manoeuvres each (Cough assist E70, Philips Respironics, Hamburg, Germany). Positive and negative pressures will be set at the individual level of each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of a NMD
- •Functional status: non-ambulatory
- •Age >5 years and < 16 years
- •Able to cooperate
- •Daily home-use of cough assist as reported by the caregivers
- •Written informed consent by the subject/caregiver
排除标准
- •Acute respiratory infection at two consecutive outpatient clinic visits (marked increase in cough, change in sputum amount or colour, fever or malaise)
- •Oxygen dependency (defined as need for oxygen to achieve a transcutaneous oxygen saturation of ≥92%)
- •Skin lesions at the chest (preventing EIT measurements)
- •Chest deformation preventing EIT measurements
研究组 & 干预措施
Conventional settings first, modified settings second
The control intervention (CON) is the conventional mode of a commercially available mechanical insufflator/exsufflator. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine.
The study intervention (MOD) is a modified mode of a commercially available mechanical insufflator/exsufflator in which the active exsufflation of the last breath of each set will be omitted. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine. This modified mode is already used in daily routine by a minority of subjects with NMD.
干预措施: Mechanical insufflation/exsufflation conventional (Device)
Conventional settings first, modified settings second
The control intervention (CON) is the conventional mode of a commercially available mechanical insufflator/exsufflator. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine.
The study intervention (MOD) is a modified mode of a commercially available mechanical insufflator/exsufflator in which the active exsufflation of the last breath of each set will be omitted. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine. This modified mode is already used in daily routine by a minority of subjects with NMD.
干预措施: Mechanical insufflation/exsufflation modified (Device)
Modified settings first, conventional settings second
The study intervention (MOD) is a modified mode of a commercially available mechanical insufflator/exsufflator in which the active exsufflation of the last breath of each set will be omitted. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine. This modified mode is already used in daily routine by a minority of subjects with NMD.
The control intervention (CON) is the conventional mode of a commercially available mechanical insufflator/exsufflator. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine.
干预措施: Mechanical insufflation/exsufflation conventional (Device)
Modified settings first, conventional settings second
The study intervention (MOD) is a modified mode of a commercially available mechanical insufflator/exsufflator in which the active exsufflation of the last breath of each set will be omitted. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine. This modified mode is already used in daily routine by a minority of subjects with NMD.
The control intervention (CON) is the conventional mode of a commercially available mechanical insufflator/exsufflator. The manoeuvre consists of 5 sets of 5 mechanical insufflations/exsufflations with individual pressure settings.
For the study, the same pressure settings will be used as during daily routine.
干预措施: Mechanical insufflation/exsufflation modified (Device)
结局指标
主要结局
Change in end-expiratory lung impedance from baseline
时间窗: 3-5 Minutes
Change of end-expiratory lung volume estimated by electrical impedance tomography from baseline to immediately after a session of mechanical insufflation/exsufflation.
次要结局
- Duration of effect(15-20 minutes)
- Change in ventilation distribution from baseline(3-5 Minutes)