Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Bronchitis/Bronchiectasis
• Intervention / Treatment: Device: VAKÜM system; Other: conventional manual ELTGOL technique

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enrico M Clini, Prof.; Email: enrico.clini@unimore.it

Study Locations

• Italy
  • Modena, Italy
    • Recruiting
    • Villa Pineta Hospital
    • Principal Investigator: Enrico M Clini, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived dyspnea	Visual Analogic Scale (VAS)	Baseline and 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak expiratory air flows	Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)	Baseline and 10 days
Change in arterial blood gases exchanges	PaO2, PaCO2, SatO2, pH	Baseline and 10 days
Change in spirometric lung volumes	Static and dynamic lung volumes	Baseline and 10 days
Change in respiratory muscle strength	Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)	Baseline and 10 days
Change in sputum volume and characteristics	Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)	Daily over 10 days
Change in quality of life	Quality of life questionnaires (CAT, MRF 28)	Baseline and 10 days

Collaborators and Investigators

• Sponsor: Villa Pineta Hospital
• Investigators: Principal Investigator: Enrico M Clini, MD, University of Modena Reggio Emilia

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): April 1, 2016

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (ESTIMATE): October 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Chest physiotherapy; Chronic respiratory diseases
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Bronchiectasis; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: 2793