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Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

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ClinicalTrials.gov Identifier: NCT01718067
Recruitment Status : Unknown
Verified December 2014 by Prof. Clini Enrico, Villa Pineta Hospital.
Recruitment status was:  Recruiting
First Posted : October 31, 2012
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, 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.


Condition or disease Intervention/treatment Phase
Chronic Bronchitis/Bronchiectasis Chronic Obstructive Pulmonary Disease Device: VAKÜM system Other: conventional manual ELTGOL technique Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

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 Name: 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




Primary Outcome Measures :
  1. Change in perceived dyspnea [ Time Frame: Baseline and 10 days ]
    Visual Analogic Scale (VAS)


Secondary Outcome Measures :
  1. Change in peak expiratory air flows [ Time Frame: Baseline and 10 days ]
    Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)

  2. Change in arterial blood gases exchanges [ Time Frame: Baseline and 10 days ]
    PaO2, PaCO2, SatO2, pH

  3. Change in spirometric lung volumes [ Time Frame: Baseline and 10 days ]
    Static and dynamic lung volumes

  4. Change in respiratory muscle strength [ Time Frame: Baseline and 10 days ]
    Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)

  5. Change in sputum volume and characteristics [ Time Frame: Daily over 10 days ]
    Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)

  6. Change in quality of life [ Time Frame: Baseline and 10 days ]
    Quality of life questionnaires (CAT, MRF 28)



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718067


Contacts
Contact: Enrico M Clini, Prof. enrico.clini@unimore.it

Locations
Italy
Villa Pineta Hospital Recruiting
Modena, Italy
Principal Investigator: Enrico M Clini, Prof.         
Sponsors and Collaborators
Villa Pineta Hospital
Investigators
Principal Investigator: Enrico M Clini, MD University of Modena Reggio Emilia

Responsible Party: Prof. Clini Enrico, Prof., Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT01718067     History of Changes
Other Study ID Numbers: 2793
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Prof. Clini Enrico, Villa Pineta Hospital:
Chest physiotherapy
Rehabilitation
Chronic respiratory diseases

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchiectasis
Bronchitis, Chronic
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections