HFCWO Vest Plus Mechanical Cough Assist Versus Cough Assist Alone on Respiratory Infections in ALS: a Pilot Trial

Hospital Universitario Virgen Macarena14 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis Respiratory Infection

Interventions

High-frequency chest wall oscillation (HFCWO) vestDEVICE

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.

Mechanical cough assistDEVICE

Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario Virgen Macarena

Seville, Andalusia, Spain

Outcomes

Primary Outcomes

Number of respiratory infections

Number of respiratory infections requiring antibiotic treatment during the study period

Time frame: 6 months (3 months intervention plus 3 months follow-up)

Secondary Outcomes

Number of hospital admissions

Number of hospital admissions due to respiratory causes during the study period

Time frame: 6 months (3 months intervention plus 3 months follow-up)

Data from ClinicalTrials.gov

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