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

NCT07473856 | Not Yet Recruiting

• 2 other identifiers: APHP240805IDRCB 2025-A01388-41
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Polyhandicap; Intrapulmonary Percussive Ventilation; Respiratory distress; Rehospitalization with respiratory decompensation; Quality of life (PolyQol); Exacerbation management at home

Outcome Measures

Primary Outcomes (1)

• Number of readmissions with respiratory decompensation

  18 months after the index hospitalization with respiratory decompensation

Secondary Outcomes (6)

• Number of days of hospitalization

  18 months after the index hospitalization with respiratory decompensation.

• Number and duration of respiratory exacerbations managed at home, emergency visits not followed by hospitalizations and unscheduled consultations

  18 months after the index hospitalization with respiratory decompensation.

• Number of days on antibiotics for respiratory issues

  18 months after the index hospitalization with respiratory decompensation.

• PolyQol scale

  At month 1, month 3, month 6, month 12, and month 18

• PERKINE Questionnaire

  At month 1, month 3, month 6, month 12, and month 18

Study Arms (2)

IPV + Manual Respiratory Physiotherapy

EXPERIMENTAL

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.

Procedure: Intrapulmonary Percussive Ventilation IPV

Manual Respiratory Physiotherapy Only

NO INTERVENTION

no intervention, current practice

Interventions

Intrapulmonary Percussive Ventilation IPV PROCEDURE

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.

Also known as: Comfort Cough II®, Percussion Ventilation Device

IPV + Manual Respiratory Physiotherapy

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Name Pediatric Pulmonology Department - Armand Trousseau Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica TAYTARD, MCU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica TAYTARD, MCU-PH

CONTACT

+33 (0)1 71 73 87 11; jessica.taytard@aphp.fr

Elsa SCHWARTZ

CONTACT

00 33 1 71 73 80 26; elsa.schwartz@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)