Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-15 @ 4:40 AM
Study NCT ID:
NCT01718067
Status:
UNKNOWN
Last Update Posted:
2014-12-10
First Post:
2012-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Vakum Technology in Patients With Chronic Hypersecretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-09', 'studyFirstSubmitDate': '2012-10-22', 'studyFirstSubmitQcDate': '2012-10-30', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in perceived dyspnea', 'timeFrame': 'Baseline and 10 days', 'description': 'Visual Analogic Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Change in peak expiratory air flows', 'timeFrame': 'Baseline and 10 days', 'description': 'Peak Expiratory Flow (PEF), Peak Cough Expiratory Flow (PCEF)'}, {'measure': 'Change in arterial blood gases exchanges', 'timeFrame': 'Baseline and 10 days', 'description': 'PaO2, PaCO2, SatO2, pH'}, {'measure': 'Change in spirometric lung volumes', 'timeFrame': 'Baseline and 10 days', 'description': 'Static and dynamic lung volumes'}, {'measure': 'Change in respiratory muscle strength', 'timeFrame': 'Baseline and 10 days', 'description': 'Maximal Expiratory Pressure (MEP), Maximal Inspiratory Pressure (MIP)'}, {'measure': 'Change in sputum volume and characteristics', 'timeFrame': 'Daily over 10 days', 'description': 'Volume, Density (D) and Purulence (P) (D and P assessed on a semi-quantitative 3-point scale)'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline and 10 days', 'description': 'Quality of life questionnaires (CAT, MRF 28)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chest physiotherapy', 'Rehabilitation', 'Chronic respiratory diseases'], 'conditions': ['Chronic Bronchitis/Bronchiectasis', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nPatients 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.\n\nSpirometric 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.\n\nAn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with chronic respiratory diseases\n* hypersecretion condition(sputum production \\>30 mL/die)\n* reduced cough efficiency (Peak Cough Expiratory Flow \\> 150 and \\< 300 L\\*min- 1)\n* patients admitted to standard pulmonary rehabilitation\n\nExclusion Criteria:\n\n* not able to use the device\n* concomitant cardiovascular or neoplastic diseases\n* utilization of Non Invasive Ventilation'}, 'identificationModule': {'nctId': 'NCT01718067', 'briefTitle': 'Efficacy of Vakum Technology in Patients With Chronic Hypersecretion', 'organization': {'class': 'OTHER', 'fullName': 'Villa Pineta Hospital'}, 'officialTitle': 'Efficacy of Vakum Technology in Patients With Chronic Hypersecretion.', 'orgStudyIdInfo': {'id': '2793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vakum', 'description': 'VAKÜM system (Free Aspire, MPR, Legnano-I) added to the conventional manual ELTGOL technique', 'interventionNames': ['Device: VAKÜM system', 'Other: conventional manual ELTGOL technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'conventional manual ELTGOL technique', 'interventionNames': ['Other: conventional manual ELTGOL technique']}], 'interventions': [{'name': 'VAKÜM system', 'type': 'DEVICE', 'otherNames': ['Free Aspire, MPR, Legnano-I'], 'description': '15 minutes, twice a day.', 'armGroupLabels': ['Vakum']}, {'name': 'conventional manual ELTGOL technique', 'type': 'OTHER', 'description': '20 minutes twice a day', 'armGroupLabels': ['Control', 'Vakum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico M Clini, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Villa Pineta Hospital', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'centralContacts': [{'name': 'Enrico M Clini, Prof.', 'role': 'CONTACT', 'email': 'enrico.clini@unimore.it'}], 'overallOfficials': [{'name': 'Enrico M Clini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Villa Pineta Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Prof. Clini Enrico', 'investigatorAffiliation': 'Villa Pineta Hospital'}}}}