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

Starting soon · Not applicable

Conditions studied: Respiratory Decompensation, Multiple Disabilities

In brief

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)

Key facts

Study ID

NCT07473856

Run by

Assistance Publique - Hôpitaux de Paris

People needed

146

Starts

2026-03-01

Expected to finish

2029-03-01

Last updated by the study team

2026-03-16

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Polyhandicap defined by:
• 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,
• Functional Independence Measure (FIM) score < 55,
• Age: 1 to 16 years,
• Hospitalization of the patient with respiratory decompensation (RD),
• Informed consent from parents/legal guardians

You may not qualify if…

• 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,
• Contraindications for the use of the medical device:
• Pneumothorax,
• Hypotension or hemodynamic instability,
• Hemoptysis,
• Participation in another interventional study.
• Patients with tracheobronchial collapse during expiration

Where it is running

• Name Pediatric Pulmonology Department - Armand Trousseau Hospital — Paris, France

Full record on ClinicalTrials.gov

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