Amyotrophic Lateral Sclerosis, Respiratory Infection
Conditions
Keywords
Amyotrophic Lateral Sclerosis High-frequency chest wall oscillation Mechanical cough assist Respiratory infections Secretion clearance ALS
Brief summary
This pilot randomised single-blind trial evaluated whether adding high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II) to mechanical cough assist improves respiratory outcomes and reduces respiratory infections and hospital admissions compared to mechanical cough assist alone in patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation.
Detailed description
Patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation (NIV) at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena (Seville, Spain) were randomised to two parallel groups. The experimental group received high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II/CC20) combined with mechanical cough assist, while the control group received mechanical cough assist alone. The intervention period lasted 3 months, followed by 3 months of follow-up. Primary outcomes included respiratory infections and hospital admissions. Secondary outcomes included respiratory function, quality of life, sleep quality, and secretion clearance capacity. The study was approved by the Ethics Committee of Hospital Universitario Virgen Macarena - Virgen del Rocío (code 2020-01) and sponsored by FISEVI (Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía).
Interventions
DEVICEHigh-frequency chest wall oscillation (HFCWO) vest
Chest wall oscillation vest delivering high-frequency vibrations to mobilise secretions, used in addition to mechanical cough assist device during the 3-month intervention period.
DEVICEMechanical cough assist
Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.
Sponsors
Hospital Universitario Virgen Macarena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Investigators assessing outcomes were blinded to treatment allocation. Blinding of participants and care providers was not feasible due to the nature of the intervention.
Intervention model description
Two parallel arms: experimental group receiving HFCWO chest vest combined with mechanical cough assist versus control group receiving mechanical cough assist alone. Randomised single-blind design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of ALS according to the Revised El Escorial criteria 2. Under follow-up at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena 3. Age between 18 and 90 years 4. Peak cough flow less than 270 L/min or forced vital capacity (FVC) less than 80% of predicted 5. Ability to travel to the Neurolab centre
Exclusion criteria
1. Need for invasive mechanical ventilation 2. Total dependence on non-invasive ventilation (NIV) 3. Severe bulbar involvement 4. Cognitive impairment 5. Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of respiratory infections | 6 months (3 months intervention plus 3 months follow-up) | Number of respiratory infections requiring antibiotic treatment during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital admissions | 6 months (3 months intervention plus 3 months follow-up) | Number of hospital admissions due to respiratory causes during the study period |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORConcepcion Romero Muñoz
Hospital Universitario Virgen Macarena
Outcome results
None listed