Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Sponsor

Villa Pineta Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01718067

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Bronchitis/Bronchiectasis Chronic Obstructive Pulmonary Disease	Device: VAKÜM system Other: conventional manual ELTGOL technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Change in perceived dyspnea [Baseline and 10 days]
Visual Analogic Scale (VAS)

Secondary Outcome Measures

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)