Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Not Applicable

• Conditions: Chronic Bronchitis/Bronchiectasis; Chronic Obstructive Pulmonary Disease
• Interventions: Device: VAKÜM system; Other: conventional manual ELTGOL technique

• Registration Number: NCT01718067
• Lead Sponsor: Villa Pineta Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-10-31
• Study Start: 2013-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vakum	conventional manual ELTGOL technique	VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique
Control	conventional manual ELTGOL technique	conventional manual ELTGOL technique
Vakum	VAKÜM system	VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique

Primary Outcome Measures

Name	Time	Method
Change in perceived dyspnea	Baseline and 10 days	Visual Analogic Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Change in peak expiratory air flows	Baseline and 10 days	Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)
Change in arterial blood gases exchanges	Baseline and 10 days	PaO2, PaCO2, SatO2, pH
Change in spirometric lung volumes	Baseline and 10 days	Static and dynamic lung volumes
Change in respiratory muscle strength	Baseline and 10 days	Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)
Change in sputum volume and characteristics	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	Baseline and 10 days	Quality of life questionnaires (CAT, MRF 28)

Trial Locations

Locations (1)

Villa Pineta Hospital; 🇮🇹 Modena, Italy