Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in perceived dyspnea
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with chronic respiratory diseases
- •hypersecretion condition(sputum production >30 mL/die)
- •reduced cough efficiency (Peak Cough Expiratory Flow > 150 and < 300 L*min- 1)
- •patients admitted to standard pulmonary rehabilitation
Exclusion Criteria
- •not able to use the device
- •concomitant cardiovascular or neoplastic diseases
- •utilization of Non Invasive Ventilation
Outcomes
Primary Outcomes
Change in perceived dyspnea
Time Frame: Baseline and 10 days
Visual Analogic Scale (VAS)
Secondary Outcomes
- Change in peak expiratory air flows(Baseline and 10 days)
- Change in arterial blood gases exchanges(Baseline and 10 days)
- Change in spirometric lung volumes(Baseline and 10 days)
- Change in respiratory muscle strength(Baseline and 10 days)
- Change in sputum volume and characteristics(Daily over 10 days)
- Change in quality of life(Baseline and 10 days)
Investigators
Prof. Clini Enrico
Prof.
Villa Pineta Hospital