Mechanical Insufflator/Exsufflator Technique in Children With Neuromuscular Disease (MINEX-2)
Neuromuscular Diseases in Children
About this trial
This is an interventional prevention trial for Neuromuscular Diseases in Children focused on measuring Lung function
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Conventional settings first, modified settings second
Modified settings first, conventional 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.
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.