Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit

NCT ID: NCT04563832

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-25
• Study Completion Date: 2022-10-31

Brief Summary

In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.

This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology

Detailed Description

During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.

Evidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control group

standardized respiratory management.

Group Type: OTHER

Standardized respiratory management program

Intervention Type: OTHER

Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years

Experimental group

same program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years)

Group Type: EXPERIMENTAL

Standardized respiratory management program

Intervention Type: OTHER

Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years

CoughAssist

Intervention Type: OTHER

self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)

Interventions

Standardized respiratory management program

Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years

Intervention Type: OTHER

CoughAssist

self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed MS diagnosis (McDonald criteria)
• EDSS ≥ 7
• Age greater than or equal to 18 years.
• Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.

Exclusion Criteria

• ENT and / or thoracic surgery less than 6 months old
• Progressive or past pneumothorax / pneumomediastinum
• Severe swallowing disorders.
• Inability to use the device under study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Raymond Poincaré

Garches, Haut de Seine, France

Site Status: RECRUITING

Countries

France

Central Contacts

Jonathan LEVY, Dr

Role: CONTACT

jonathan.levy2@aphp.fr

+33 147107900

Hélène PRIGENT, Pr

Role: CONTACT

helene.prigent@aphp.fr

+33 147107900

Facility Contacts

Jonathan LEVY, Dr

Role: primary

01.4710.70.60

Other Identifiers

APHP2020

Identifier Type: -

Identifier Source: org_study_id