Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.
Mechanical devices to increase the individual's bronchial hygiene are commonly used to
assist patients with chronic retention of secretions. VAKÜM technology has been recently
developed with the aim to improve the respiratory condition in hypersecretive patients
suffering from chronic respiratory diseases.
The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients
with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.
Patients with chronic respiratory diseases, hypersecretion (sputum production >30 mL/die),
and reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min-1) referred
to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind
multicentre randomized trial with consecutive recruitment. Following a preliminary run-in
period, group comparison will be made between Intervention group using VAKÜM system (Free
Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group
using manual ELTGOL alone over 10 daily sessions.
Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of
life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale),
sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory
air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary
outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point
(SD 5) group difference change in the primary outcome at the end of the study period as
significant at the 0.05 level, at least 42 patients per group are needed. The minimum target
sample size will be then fixed at 50 patients per group.
An higher and faster significant reduction of the perceived dyspnea is supposed in the
Intervention group. Additional benefits among the secondary outcomes are also hypothesised
in the same group.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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