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

Villa Pineta Hospital

Status and phase: Completed; Phase 4

Conditions: Chronic Hypersecretions

Treatments: Procedure: MABT (Manually assisted breathing techniques); Device: TPEP device (UNIKO)

Study type: Interventional

Funder types: Other

Identifiers

NCT00700388

69/08

Details and patient eligibility

About

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

Full description

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)

Enrollment: 100 patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

TPEP added to conventional manually assisted breathing techniques (MABT)

Treatment:

Device: TPEP device (UNIKO)

2

Active Comparator group

Description:

Manually assisted breathing techniques (MABT) alone

Treatment:

Procedure: MABT (Manually assisted breathing techniques)