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

NCT ID: NCT00700388

Last Updated: 2011-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-12-31

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)

Conditions

Chronic Hypersecretions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

TPEP added to conventional manually assisted breathing techniques (MABT)

Group Type: EXPERIMENTAL

TPEP device (UNIKO)

Intervention Type: 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.

2

Manually assisted breathing techniques (MABT) alone

Group Type: ACTIVE_COMPARATOR

MABT (Manually assisted breathing techniques)

Intervention Type: PROCEDURE

Conventionally manually assisted breathing techniques

Interventions

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.

Intervention Type: DEVICE

MABT (Manually assisted breathing techniques)

Conventionally manually assisted breathing techniques

Intervention Type: PROCEDURE

Other Intervention Names

UNIKO; MABT

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Modena and Reggio Emilia

OTHER

Sponsor Role: collaborator

Villa Pineta Hospital

OTHER

Sponsor Role: lead

Responsible Party

University of Modena - Villa Pineta Hospital

Principal Investigators

Enrico M. Clini, MD

Role: STUDY_DIRECTOR

University of Modena - Villa Pineta Hospital

Nicolino Ambrosino, MD

Role: STUDY_CHAIR

AOU Pisana - Cisanello (Pisa)

Locations

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

Ospedale San Raffaele IRCCS

Volterra, Roma, Italy

Ospedale San Giuseppe - Riabilitazione Specialistica

Milan, , Italy

Countries

Italy

Other Identifiers

69/08

Identifier Type: -

Identifier Source: org_study_id