Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion

Villa Pineta Hospital100 enrolled

Overview

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

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: 1. Sputum characteristics 2. Daily sputum volume 3. Perceived sensation 4. Lung functions (as assessed by spirometry and RM strength)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Chronic Hypersecretions

Interventions

TPEP device (UNIKO)DEVICE

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.

MABT (Manually assisted breathing techniques)PROCEDURE

Conventionally manually assisted breathing techniques

Eligibility

Sex: ALLMin age: 25 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (6)

Fondazione Maugeri IRCCS

Lumezzane, Brescia, Italy

Villa Pineta Hospital

Pavullo nel Frignano, Modena, Italy

Fondazione Maugeri IRCCS

Veruno, Novara, Italy

Centro Riabilitazione Auxilium Vitae

Volterra, Pisa, Italy

Outcomes

Primary Outcomes

arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)

Time frame: Day 10

Secondary Outcomes

Sputum volume

Time frame: Day 1 to 10

Sputum characteristics

Time frame: Day 1 to 10

Individual's perceived sensation (VAS scale)

Time frame: Day 1 to 10

Lung function (volumes and respiratory muscle performance)

Time frame: Day 1 - 3 - 10

Data from ClinicalTrials.gov

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