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

NCT00700388 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-08-04

No results posted yet for this study

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

Conditions

  • Chronic Hypersecretions

Interventions

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

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • Villa Pineta Hospital

    lead OTHER

Principal Investigators

  • Enrico M. Clini, MD · University of Modena - Villa Pineta Hospital

  • Nicolino Ambrosino, MD · AOU Pisana - Cisanello (Pisa)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700388 on ClinicalTrials.gov