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

NCT07473856 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-03-16

No results posted yet for this 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)

Conditions

  • Respiratory Decompensation
  • Multiple Disabilities

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jessica TAYTARD, MCU-PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07473856 on ClinicalTrials.gov