Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

NCT01718067 | Unknown

• 1 other identifier: 2793
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Bronchitis/Bronchiectasis; Chronic Obstructive Pulmonary Disease

Keywords

Chest physiotherapy; Rehabilitation; Chronic respiratory diseases

Outcome Measures

Primary Outcomes (1)

• Change in perceived dyspnea

  Visual Analogic Scale (VAS)

  Baseline and 10 days

Secondary Outcomes (6)

• Change in peak expiratory air flows

  Baseline and 10 days

• Change in arterial blood gases exchanges

  Baseline and 10 days

• Change in spirometric lung volumes

  Baseline and 10 days

• Change in respiratory muscle strength

  Baseline and 10 days

• Change in sputum volume and characteristics

  Daily over 10 days

Study Arms (2)

Vakum

EXPERIMENTAL

VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique

Device: VAKÜM system; Other: conventional manual ELTGOL technique

Control

ACTIVE COMPARATOR

conventional manual ELTGOL technique

Other: conventional manual ELTGOL technique

Interventions

VAKÜM system DEVICE

15 minutes, twice a day.

Also known as: Free Aspire, MPR, Legnano-I

Vakum

conventional manual ELTGOL technique OTHER

20 minutes twice a day

Control; Vakum

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not able to use the device
• concomitant cardiovascular or neoplastic diseases
• utilization of Non Invasive Ventilation

Sponsors & Collaborators

• Villa Pineta Hospital: lead

Study Sites (1)

Villa Pineta Hospital

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Bronchitis, Chronic; Bronchiectasis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico M Clini, MD

  University of Modena Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico M Clini, Prof.

CONTACT

enrico.clini@unimore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 31, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

IT (1)