Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-28 @ 10:43 AM
Study NCT ID:
NCT01300403
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045853', 'term': 'Exhalation'}], 'ancestors': [{'id': 'D015656', 'term': 'Respiratory Mechanics'}, {'id': 'D012119', 'term': 'Respiration'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic and static lung volumes', 'timeFrame': 'In the week 1, 2 and 3. Before (baseline) and after each intervention.', 'description': 'Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.'}], 'secondaryOutcomes': [{'measure': 'Sputum production', 'timeFrame': 'Sputum was colected during the interventions', 'description': 'The expectorated secretions were collected using a sputum trap and quantificated by its dry weight.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the acute physiological effects of expiration with the glottis open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in patients with bronchiectasis and, secondarily, to study the effect of these techniques in sputum production.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with clinical and radiological criteria of bronchiectasis\n\nExclusion Criteria:\n\n* heart failure\n* pneumonia\n* chest pain\n* inability to perform the procedures\n* asthma\n* cystic fibrosis'}, 'identificationModule': {'nctId': 'NCT01300403', 'briefTitle': 'Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Acute Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Dynamic and Static Pulmonary Volumes of Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': '02/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLUTTER', 'description': 'Since this was a crossover study, all patients performed all interventions in a randomized order.', 'interventionNames': ['Other: Flutter valve']}, {'type': 'EXPERIMENTAL', 'label': 'ELTGOL', 'description': 'Since this was a crossover study, all patients performed all interventions in a randomized order.', 'interventionNames': ['Other: expiration with the glottis open in lateral posture (ELTGOL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL', 'description': 'Since this was a crossover study, all patients performed all interventions in a randomized order.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Flutter valve', 'type': 'OTHER', 'description': 'Flutter valve is a physiotherapy device commonly used for the treatment of pulmonary hypersecretive conditions. The patients is taught to exhale through the device, producing positive expiratory pressure and flow oscillations. In this study the intervention took 15 minutes. During this period the patients were free to cough.', 'armGroupLabels': ['FLUTTER']}, {'name': 'expiration with the glottis open in lateral posture (ELTGOL)', 'type': 'OTHER', 'description': 'This technique is a maneuver of slow expiration with the glottis open, with the subject in lateral posture. The patients performed three sets of 10 repetitions in left and right lateral decubitus.', 'armGroupLabels': ['ELTGOL']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.', 'armGroupLabels': ['CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20550-170', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitário Pedro Ernesto', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Fernando S Guimarães, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Universitário Augusto Motta', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Fernando Silva Guimarães', 'oldOrganization': 'Augusto Motta University Center'}}}}