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

Phase 4

Completed

• Conditions: Chronic Hypersecretions
• Interventions: Device: TPEP device (UNIKO); Procedure: MABT (Manually assisted breathing techniques)

• Registration Number: NCT00700388
• Lead Sponsor: Villa Pineta Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-07
• Status Verified: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TPEP device (UNIKO)	TPEP added to conventional manually assisted breathing techniques (MABT)
2	MABT (Manually assisted breathing techniques)	Manually assisted breathing techniques (MABT) alone

Primary Outcome Measures

Name	Time	Method
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)	Day 10

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Villa Pineta Hospital; 🇮🇹 Pavullo nel Frignano, Modena, Italy

Centro Riabilitazione Auxilium Vitae; 🇮🇹 Volterra, Pisa, Italy

Fondazione Maugeri IRCCS; 🇮🇹 Veruno, Novara, Italy

Ospedale San Raffaele IRCCS; 🇮🇹 Volterra, Roma, Italy

Ospedale San Giuseppe - Riabilitazione Specialistica; 🇮🇹 Milano, Italy