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

This study has been completed.
Sponsor:
Collaborator:
University of Modena and Reggio Emilia
Information provided by:
Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT00700388
First received: June 17, 2008
Last updated: August 2, 2011
Last verified: January 2010

June 17, 2008
August 2, 2011
July 2008
December 2010   (final data collection date for primary outcome measure)
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index) [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00700388 on ClinicalTrials.gov Archive Site
  • Sputum volume [ Time Frame: Day 1 to 10 ] [ Designated as safety issue: No ]
  • Sputum characteristics [ Time Frame: Day 1 to 10 ] [ Designated as safety issue: No ]
  • Individual's perceived sensation (VAS scale) [ Time Frame: Day 1 to 10 ] [ Designated as safety issue: No ]
  • Lung function (volumes and respiratory muscle performance) [ Time Frame: Day 1 - 3 - 10 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Temporary Positive Expiratory Pressure (TPEP) in Chronic Hypersecretion
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

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)
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Hypersecretions
  • 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 Name: UNIKO
  • Procedure: MABT (Manually assisted breathing techniques)
    Conventionally manually assisted breathing techniques
    Other Name: MABT
  • Experimental: 1
    TPEP added to conventional manually assisted breathing techniques (MABT)
    Intervention: Device: TPEP device (UNIKO)
  • Active Comparator: 2
    Manually assisted breathing techniques (MABT) alone
    Intervention: Procedure: MABT (Manually assisted breathing techniques)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
December 2010   (final data collection date for primary outcome measure)

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)
Both
25 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00700388
69/08
Yes
Prof. Enrico Clini, University of Modena - Villa Pineta Hospital
Villa Pineta Hospital
University of Modena and Reggio Emilia
Study Director: Enrico M. Clini, MD University of Modena - Villa Pineta Hospital
Study Chair: Nicolino Ambrosino, MD AOU Pisana - Cisanello (Pisa)
Villa Pineta Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP