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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hypersecretions
• Intervention / Treatment: Device: TPEP device (UNIKO); Procedure: MABT (Manually assisted breathing techniques)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20100
    • Ospedale San Giuseppe - Riabilitazione Specialistica
  • Brescia
    • Lumezzane, Brescia, Italy
      • Fondazione Maugeri IRCCS
  • Modena
    • Pavullo nel Frignano, Modena, Italy, 41026
      • Villa Pineta Hospital
  • Novara
    • Veruno, Novara, Italy
      • Fondazione Maugeri IRCCS
  • Pisa
    • Volterra, Pisa, Italy
      • Centro Riabilitazione Auxilium Vitae
  • Roma
    • Volterra, Roma, Italy, 00049
      • Ospedale San Raffaele Irccs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; TPEP added to conventional manually assisted breathing techniques (MABT)	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.; Other Names: UNIKO
Active Comparator: 2; Manually assisted breathing techniques (MABT) alone	Procedure: MABT (Manually assisted breathing techniques); Conventionally manually assisted breathing techniques; Other Names: MABT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)	Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Villa Pineta Hospital
• Collaborators: University of Modena and Reggio Emilia
• Investigators: Study Director: Enrico M. Clini, MD, University of Modena - Villa Pineta Hospital; Study Chair: Nicolino Ambrosino, MD, AOU Pisana - Cisanello (Pisa)

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 17, 2008
• First Posted (Estimate): June 18, 2008

Study Record Updates

• Last Update Posted (Estimate): August 4, 2011
• Last Update Submitted That Met QC Criteria: August 2, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: COPD; Bronchiectasis; Chronic bronchitis
• Other Study ID Numbers: 69/08