Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01718067
• Other study ID #: 2793
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2012
• Last updated: December 9, 2014
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2014
• Source: Villa Pineta Hospital
• Contact: Enrico M Clini, Prof.
• Email: enrico.clini[@]unimore.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis/Bronchiectasis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• VAKÜM system
15 minutes, twice a day.

Other:
• conventional manual ELTGOL technique
20 minutes twice a day

Locations

Country	Name	City	State
Italy	Villa Pineta Hospital	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Villa Pineta Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived dyspnea	Visual Analogic Scale (VAS)	Baseline and 10 days	Yes
Secondary	Change in peak expiratory air flows	Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)	Baseline and 10 days	Yes
Secondary	Change in arterial blood gases exchanges	PaO2, PaCO2, SatO2, pH	Baseline and 10 days	Yes
Secondary	Change in spirometric lung volumes	Static and dynamic lung volumes	Baseline and 10 days	Yes
Secondary	Change in respiratory muscle strength	Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)	Baseline and 10 days	Yes
Secondary	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	No
Secondary	Change in quality of life	Quality of life questionnaires (CAT, MRF 28)	Baseline and 10 days	No