Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). These are the leading cause of mortality (50 to 80%, average age of death: 21 years) and the cause of repeated hospitalizations.
Respiratory care for these children is therefore a major challenge. In respiratory physiotherapy, this can be achieved through manual techniques and/or instrumental techniques such as intrapulmonary percussive ventilation (IPV), which is particularly useful in this population because it does not require active cooperation.
The main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV at home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone.This is a multicenter, randomized controlled superiority trial with two parallel groups.
All centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with respiratory decompensation (RD). After consent has been signed by the parents or legal guardians, the patient will be randomized into one of the two study groups:
* Control group: manual respiratory physiotherapy. * Intervention group: intrapulmonary Percussive Ventilation (IPV)
Causal brain injury or lesion occurring before the age of 3 years,
Severe or profound intellectual disability according to DSM IV definition
Motor disability: paraplegia/quadriplegia, hemiparesis, ataxia, and/or extrapyramidal motor disorders,
Gross Motor Function Classification System (GMFCS) score of IV or V,
Associated neuromuscular disease
Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,
Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,
Pneumothorax,
Parallel
Intrapulmonary Percussive Ventilation IPV
Procedure/SurgeryAfter the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home.
Number of readmissions with respiratory decompensation
Number of days of hospitalization
Hospital days with respiratory decompensation in conventional service and in the intensive Care Unit
Number and duration of respiratory exacerbations managed at home, emergency visits not followed by hospitalizations and unscheduled consultations
Number of days on antibiotics for respiratory issues
Track antibiotic use for respiratory conditions outside of baseline treatment
PolyQol scale
change in the child's quality of life using the PolyQol scale
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