MS-COUGH: Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Control group standardized respiratory management. |
Other: Standardized respiratory management program
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
|
| Experimental: 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) |
Other: Standardized respiratory management program
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
Other: CoughAssist
self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)
|
Outcome Measures
Primary Outcome Measures
- Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS. [24 months]
This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy
Secondary Outcome Measures
- Effect of COUGH-ASSIST on slowing the decline in respiratory function, [12 months and 24 months]
This will be demonstrated by monitoring respiratory function by spirometry
- Functional effectiveness of COUGH-ASSIST [12 months and 24 months]
By using the goal attainmentscaling method (GAS)
- Tolerance and compliance with COUGH-ASSIST, [24 months]
This will be evaluated via an online "patient reported outcomes form" and data readings from the internal memory of the COUGH-ASSIST
- Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection [24 months]
This will be evaluate by the number of serious respiratory infection
Eligibility Criteria
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
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Progressive or past pneumothorax / pneumomediastinum
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Severe swallowing disorders.
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Inability to use the device under study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Raymond Poincaré | Garches | Haut De Seine | France | 92380 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP2020