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

NCT07473856 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2026-03

Last updated

2026-03-16

Condition(s) studied

Respiratory DecompensationMultiple Disabilities

Investigational drug(s) / intervention(s)

Intrapulmonary Percussive Ventilation IPV

Intrapulmonary Percussive Ventilation IPV: After 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.

Study summary

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

Sex

ALL

Min age

1 Year

Max age

16 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Number of readmissions with respiratory decompensation — 18 months after the index hospitalization with respiratory decompensation

Trial sites (1)

Facility	City	Region	Status
Name Pediatric Pulmonology Department - Armand Trousseau Hospital	Paris	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07473856 on ClinicalTrials.gov ↗ ← All trials in France