Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02460757
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2015-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glottic Width and Respiratory Flow in Patients With Various Lung Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007828', 'term': 'Laryngoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angle of the glottic width', 'timeFrame': '18 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glottic movement', 'emphysema', 'copd', 'vocal cord'], 'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'In this study the investigators examine the glottic width and the respiratory flow at rest in patients with various lung disease. The investigators postulated that a positive expiratory pressure is created through the narrowing of the glottic width in patients with hyperinflation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with various lung diseases in a primary care clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication for a bronchoscopy\n* Minimum age of 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients requiring mechanical ventilation during bronchoscopy\n* Disease of the larynx\n* Inability to breathe through the mouthpiece'}, 'identificationModule': {'nctId': 'NCT02460757', 'briefTitle': 'Glottic Width and Respiratory Flow in Patients With Various Lung Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Glottic Width and Respiratory Flow in Patients With Various Lung Diseases', 'orgStudyIdInfo': {'id': 'RLKEssenVC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COPD', 'interventionNames': ['Other: Laryngoscopy']}, {'label': 'Patients with interstitial lung disease', 'interventionNames': ['Other: Laryngoscopy']}, {'label': 'Healthy subjects', 'interventionNames': ['Other: Laryngoscopy']}], 'interventions': [{'name': 'Laryngoscopy', 'type': 'OTHER', 'description': 'Observation of glottic width in different arms', 'armGroupLabels': ['Healthy subjects', 'Patients with COPD', 'Patients with interstitial lung disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'facility': 'Ruhrlandklinik', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jane Winantea', 'investigatorAffiliation': 'University Hospital, Essen'}}}}