Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
NCT ID: NCT01718067
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2013-01-31
2016-04-30
Brief Summary
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The aim of this study is to assess the clinical efficacy of VAKÜM technology in patients with hypersecretion, and chronic respiratory diseases a clinical trial has been designed.
Patients with chronic respiratory diseases, hypersecretion (sputum production \>30 mL/die), and reduced cough efficiency (Peak Cough Expiratory Flow \> 150 and \< 300 L\*min-1) referred to standard pulmonary rehabilitation (PR) will be included. Study design is a single-blind multicentre randomized trial with consecutive recruitment. Following a preliminary run-in period, group comparison will be made between Intervention group using VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique, and Control group using manual ELTGOL alone over 10 daily sessions.
Spirometric lung volumes, respiratory muscle strength, arterial blood gases, and quality of life will be recorded in both groups pre-to-post PR. Perceived dyspnea (by VAS scale), sputum volume and characteristics (on a semi-quantitative 3-point scale) and peak expiratory air flows (PEF and PCEF) will be registered on a daily basis over the study period. Primary outcome is the change in perceived dyspnea; in order to ensure 80% power to detect a 5 point (SD 5) group difference change in the primary outcome at the end of the study period as significant at the 0.05 level, at least 42 patients per group are needed. The minimum target sample size will be then fixed at 50 patients per group.
An higher and faster significant reduction of the perceived dyspnea is supposed in the Intervention group. Additional benefits among the secondary outcomes are also hypothesised in the same group.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Vakum
VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique
VAKÜM system
15 minutes, twice a day.
conventional manual ELTGOL technique
20 minutes twice a day
Control
conventional manual ELTGOL technique
conventional manual ELTGOL technique
20 minutes twice a day
Interventions
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VAKÜM system
15 minutes, twice a day.
conventional manual ELTGOL technique
20 minutes twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* hypersecretion condition(sputum production \>30 mL/die)
* reduced cough efficiency (Peak Cough Expiratory Flow \> 150 and \< 300 L\*min- 1)
* patients admitted to standard pulmonary rehabilitation
Exclusion Criteria
* concomitant cardiovascular or neoplastic diseases
* utilization of Non Invasive Ventilation
40 Years
ALL
No
Sponsors
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Villa Pineta Hospital
OTHER
Responsible Party
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Prof. Clini Enrico
Prof.
Principal Investigators
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Enrico M Clini, MD
Role: PRINCIPAL_INVESTIGATOR
University of Modena Reggio Emilia
Locations
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Villa Pineta Hospital
Modena, , Italy
Countries
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Central Contacts
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Other Identifiers
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2793
Identifier Type: -
Identifier Source: org_study_id