Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
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Purpose
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 | Intervention |
|---|---|
|
Chronic Bronchitis/Bronchiectasis Chronic Obstructive Pulmonary Disease |
Device: VAKÜM system Other: conventional manual ELTGOL technique |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Efficacy of Vakum Technology in Patients With Chronic Hypersecretion. |
- Change in perceived dyspnea [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]Visual Analogic Scale (VAS)
- Change in peak expiratory air flows [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)
- Change in arterial blood gases exchanges [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]PaO2, PaCO2, SatO2, pH
- Change in spirometric lung volumes [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]Static and dynamic lung volumes
- Change in respiratory muscle strength [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)
- Change in sputum volume and characteristics [ Time Frame: Daily over 10 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Quality of life questionnaires (CAT, MRF 28)
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vakum
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-I
Other: 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
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with chronic respiratory diseases
- 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:
- not able to use the device
- concomitant cardiovascular or neoplastic diseases
- utilization of Non Invasive Ventilation
Contacts and Locations More Information
No publications provided
| Responsible Party: | Prof. Clini Enrico, Prof., Villa Pineta Hospital |
| ClinicalTrials.gov Identifier: | NCT01718067 History of Changes |
| Other Study ID Numbers: | 2793 |
| Study First Received: | October 22, 2012 |
| Last Updated: | October 30, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Villa Pineta Hospital:
|
Chest physiotherapy Rehabilitation Chronic respiratory diseases |
Additional relevant MeSH terms:
|
Bronchiectasis Bronchitis Bronchitis, Chronic Lung Diseases Respiration Disorders |
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013