Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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)

Eligibility criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Intrapulmonary Percussive Ventilation IPV

Treatment groups

146 Participants
are divided into 2 treatment groups