Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
|ClinicalTrials.gov Identifier: NCT01718067|
Recruitment Status : Unknown
Verified December 2014 by Prof. Clini Enrico, Villa Pineta Hospital.
Recruitment status was: Recruiting
First Posted : October 31, 2012
Last Update Posted : December 10, 2014
Mechanical devices to increase the individual's bronchial hygiene are commonly used to assist patients with chronic retention of secretions. VAKÜM technology has been recently developed with the aim to improve the respiratory condition in hypersecretive patients suffering from chronic respiratory diseases.
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Bronchitis/Bronchiectasis Chronic Obstructive Pulmonary Disease||Device: VAKÜM system Other: conventional manual ELTGOL technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||April 2016|
VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique
Device: VAKÜM system
15 minutes, twice a day.
Other Name: Free Aspire, MPR, Legnano-IOther: conventional manual ELTGOL technique
20 minutes twice a day
Active Comparator: Control
conventional manual ELTGOL technique
Other: conventional manual ELTGOL technique
20 minutes twice a day
- Change in perceived dyspnea [ Time Frame: Baseline and 10 days ]Visual Analogic Scale (VAS)
- Change in peak expiratory air flows [ Time Frame: Baseline and 10 days ]Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)
- Change in arterial blood gases exchanges [ Time Frame: Baseline and 10 days ]PaO2, PaCO2, SatO2, pH
- Change in spirometric lung volumes [ Time Frame: Baseline and 10 days ]Static and dynamic lung volumes
- Change in respiratory muscle strength [ Time Frame: Baseline and 10 days ]Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)
- Change in sputum volume and characteristics [ Time Frame: Daily over 10 days ]Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)
- Change in quality of life [ Time Frame: Baseline and 10 days ]Quality of life questionnaires (CAT, MRF 28)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718067
|Contact: Enrico M Clini, Prof.||firstname.lastname@example.org|
|Villa Pineta Hospital||Recruiting|
|Principal Investigator: Enrico M Clini, Prof.|
|Principal Investigator:||Enrico M Clini, MD||University of Modena Reggio Emilia|