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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Other: Standardized respiratory management program; Other: CoughAssist

Study type: Interventional

Funder types: Other

Identifiers

NCT04563832

APHP2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Control group

Other group

Description:

standardized respiratory management.

Treatment:

Other: Standardized respiratory management program

Experimental group

Experimental group

Description:

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)

Treatment:

Other: Standardized respiratory management program

Other: CoughAssist