Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.

Conditions
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Chronic Bronchitis/Bronchiectasis, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: VAKÜM system
* Other: conventional manual ELTGOL technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vakum<br>VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique | Device: VAKÜM system<br>* 15 minutes, twice a day.<br>* Other names: Free Aspire, MPR, Legnano-I;Other: conventional manual ELTGOL technique<br>* 20 minutes twice a day<br>|
| Active Comparator: Control<br>conventional manual ELTGOL technique | Other: conventional manual ELTGOL technique<br>* 20 minutes twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived dyspnea | Visual Analogic Scale (VAS) | Baseline and 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak expiratory air flows | Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF) | Baseline and 10 days | 
| Change in arterial blood gases exchanges | PaO2, PaCO2, SatO2, pH | Baseline and 10 days | 
| Change in spirometric lung volumes | Static and dynamic lung volumes | Baseline and 10 days | 
| Change in respiratory muscle strength | Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP) | Baseline and 10 days | 
| Change in sputum volume and characteristics | Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale) | Daily over 10 days | 
| Change in quality of life | Quality of life questionnaires (CAT, MRF 28) | Baseline and 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest physiotherapy, Rehabilitation, Chronic respiratory diseases