Efficacy of Temporary Positive Expiratory Pressure (TPEP) in 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 in patients with chronic retention of secretions and abnormal cough reflex. In this clinical context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been recently developed with the aim to improve the respiratory condition in patients suffering from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal competence of the cough reflex

Detailed Description
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This is a single-blind multicentre controlled randomized trial with consecutive recruitment. Randomization list by blocks will be available. Group comparison will be made between active therapies including TPEP added to conventional MABT (Intervention) or MABT alone (Control). Active therapy will last 10 consecutive daily sessions in both groups. Primary outcome Efficacy comparison on change in: a.arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) Secondary outcomes Efficacy comparison on change in: Sputum characteristics Daily sputum volume Perceived sensation Lung functions (as assessed by spirometry and RM strength)

Official Title
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Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion

Conditions
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Chronic Hypersecretions

Intervention / Treatment
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* Device: TPEP device (UNIKO)
* Procedure: MABT (Manually assisted breathing techniques)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic hypersecretion as defined by > 30 mL/die sputum production (7) chronic airway obstruction (by definition) COPD, bronchiectasis, asthma, cystic disease, etc. with or without chronic respiratory failure adulthood smoking or non-smoking habit Peak Cough Expiratory Flow > 150 L*min-1 (5) willingness to participate Exclusion Criteria: childhood presence of acute exacerbation severe concomitant cardiovascular diseases concomitant neoplastic diseases non compliance/adherence to TPEP concomitant use of chronic mechanical ventilation use of amynophyllines and/or any active drugs (e.g. N-Acetyl-Cysteine)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 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: 1<br>TPEP added to conventional manually assisted breathing techniques (MABT) | Device: TPEP device (UNIKO)<br>* This technique is mainly based on a continuous low-pressure insufflation in the airways, which is likely to reduce (or even avoid) the potential pressure-related damages of other commonly used devices. This device should be used only in those individuals who are showing a normal competence of their cough reflex, thus it should be considered as a means which may help those techniques normally adopted for the individual's bronchial hygiene.<br>* Other names: UNIKO;|
| Active Comparator: 2<br>Manually assisted breathing techniques (MABT) alone | Procedure: MABT (Manually assisted breathing techniques)<br>* Conventionally manually assisted breathing techniques<br>* Other names: MABT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) |  | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum volume |  | Day 1 to 10 | 
| Sputum characteristics |  | Day 1 to 10 | 
| Individual's perceived sensation (VAS scale) |  | Day 1 to 10 | 
| Lung function (volumes and respiratory muscle performance) |  | Day 1 - 3 - 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic bronchitis, COPD, Bronchiectasis