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Completed

NCT Number: NCT00700388

Efficacy of Temporary Positive Expiratory Pressure (TPEP) in 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

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Key information

Conditions

Chronic Hypersecretions Bronchial Diseases Bronchiectasis Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fondazione Maugeri IRCCS, Lumezzane, Brescia, Italy

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About this study

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:

  • Sputum characteristics
  • Daily sputum volume
  • Perceived sensation
  • Lung functions (as assessed by spirometry and RM strength)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TPEP device (UNIKO)

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.

Other names: UNIKO

MABT (Manually assisted breathing techniques)

Procedure

Conventionally manually assisted breathing techniques

Other names: MABT

Primary outcomes

  1. arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)

    Time frame: Day 10

Secondary outcomes

  1. Sputum volume

    Time frame: Day 1 to 10

  2. Sputum characteristics

    Time frame: Day 1 to 10

  3. Individual's perceived sensation (VAS scale)

    Time frame: Day 1 to 10

  4. Lung function (volumes and respiratory muscle performance)

    Time frame: Day 1 - 3 - 10

Sponsors and collaborators

Lead sponsor

Villa Pineta Hospital

Other

Collaborators

  • University of Modena and Reggio Emilia

Registry information

Official study title

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

Acronym: UNIKO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2008
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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