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Efficacy of Vakum Technology in Patients With Chronic Hypersecretion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Villa Pineta Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT01718067
First received: October 22, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention
Chronic Bronchitis/Bronchiectasis
Chronic Obstructive Pulmonary Disease
Device: VAKÜM system
Other: conventional manual ELTGOL technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.

Resource links provided by NLM:


Further study details as provided by Villa Pineta Hospital:

Primary Outcome Measures:
  • Change in perceived dyspnea [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]
    Visual Analogic Scale (VAS)


Secondary Outcome Measures:
  • Change in peak expiratory air flows [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]
    Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)

  • Change in arterial blood gases exchanges [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]
    PaO2, PaCO2, SatO2, pH

  • Change in spirometric lung volumes [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]
    Static and dynamic lung volumes

  • Change in respiratory muscle strength [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: Yes ]
    Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)

  • Change in sputum volume and characteristics [ Time Frame: Daily over 10 days ] [ Designated as safety issue: No ]
    Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)

  • Change in quality of life [ Time Frame: Baseline and 10 days ] [ Designated as safety issue: No ]
    Quality of life questionnaires (CAT, MRF 28)


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718067

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

No publications provided

Responsible Party: Prof. Clini Enrico, Prof., Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT01718067     History of Changes
Other Study ID Numbers: 2793
Study First Received: October 22, 2012
Last Updated: October 30, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Villa Pineta Hospital:
Chest physiotherapy
Rehabilitation
Chronic respiratory diseases

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

ClinicalTrials.gov processed this record on November 25, 2014