Clinical trial NCT01718067: Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
Official title: Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Bronchitis/Bronchiectasis
Chronic Obstructive Pulmonary Disease
Keywords: Chest physiotherapy
Rehabilitation
Chronic respiratory diseases
Lead sponsor: Villa Pineta Hospital
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in perceived dyspnea
timeFrame: Baseline and 10 days
Secondary outcomes:
measure: Change in peak expiratory air flows
timeFrame: Baseline and 10 days
measure: Change in arterial blood gases exchanges
timeFrame: Baseline and 10 days
measure: Change in spirometric lung volumes
timeFrame: Baseline and 10 days
measure: Change in respiratory muscle strength
timeFrame: Baseline and 10 days
measure: Change in sputum volume and characteristics
timeFrame: Daily over 10 days
measure: Change in quality of life
timeFrame: Baseline and 10 days
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Villa Pineta Hospital
Study officials:
affiliation: University of Modena Reggio Emilia
name: Enrico M Clini, MD
role: PRINCIPAL_INVESTIGATOR
References: