Self-administered Hyperinsufflation Chest on the Risk of Low Respirato
Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Standardized respiratory management program
- CoughAssist
What it measured
Main 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
Other measures (4)
Effect of COUGH-ASSIST on slowing the decline in respiratory function,
12 months and 24 months
Functional effectiveness of COUGH-ASSIST
12 months and 24 months
Tolerance and compliance with COUGH-ASSIST,
24 months
Thinking and memoryQuality of life (reported by participants)Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
24 months
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Nov 2021
Main results due
Oct 2022
Finished
Oct 2022