NCT00700388

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Villa Pineta Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Chronic Hypersecretions

Interventions

Type	Name	Description
DEVICE	TPEP device (UNIKO)	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.
PROCEDURE	MABT (Manually assisted breathing techniques)	Conventionally manually assisted breathing techniques

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-06-18
• Last updated: 2011-08-04

Locations

6 sites across 1 country: Italy