Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02237651
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Anesthesia / Bronchoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-09', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Equally', 'timeFrame': '30 min.', 'description': 'The primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anesthesia', 'bronchosocopy', 'lung transplantation'], 'conditions': ['Equally of Delivery Systems of Local Anesthesia in Bronchoscopy']}, 'referencesModule': {'references': [{'pmid': '26978775', 'type': 'DERIVED', 'citation': 'Fuehner T, Fuge J, Jungen M, Buck A, Suhling H, Welte T, Gottlieb J, Greer M. Topical Nasal Anesthesia in Flexible Bronchoscopy--A Cross-Over Comparison between Two Devices. PLoS One. 2016 Mar 15;11(3):e0150905. doi: 10.1371/journal.pone.0150905. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to compare a simplified single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical nasopharyngeal anesthesia in comparison to a multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany in terms of patient self-rated nasopharyngeal symptoms.', 'detailedDescription': 'Patients included in the first half of the study (topical anesthesia with the Laryngeal atomizer) and with need for another bronchoscopy in the second half of the study (topical anesthesia with the Intranasal Mucosal Atomization Device) will be asked to repeat the questionnaire after the second bronchoscopy to allow in-patient comparison.\n\nDescription of the primary efficacy analysis and population:\n\nThe primary endpoint of patient self-rated anesthesia by visual analogue scale after topical nasopharyngeal anesthesia for bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after lung transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients after lung transplantation (single, double or combined)\n* Informed consent\n* outpatient bronchoscopy\n\nExclusion Criteria:\n\n* Oxygen requirement at rest\n* Need for peri-interventional sedation\n* limited German language skills or other reasons which might impair patient communication or computer handling'}, 'identificationModule': {'nctId': 'NCT02237651', 'acronym': 'TNA', 'briefTitle': 'Topical Anesthesia / Bronchoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Topical Nasopharyngeal Anesthesia in Outpatient Bronchoscopy', 'orgStudyIdInfo': {'id': 'MHH 09/03/2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'topical anesthesia multi-use device', 'description': 'anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany', 'interventionNames': ['Device: topical anesthesia multi-use device']}, {'label': 'topical anesthesia Intranasal Mucosal Atomization', 'description': 'single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia', 'interventionNames': ['Device: topical anesthesia Intranasal Mucosal Atomization']}], 'interventions': [{'name': 'topical anesthesia multi-use device', 'type': 'DEVICE', 'otherNames': ['anesthesia with multi-use device (Laryngeal atomizer, Karl Storz, Tuttlingen, Germany'], 'armGroupLabels': ['topical anesthesia multi-use device']}, {'name': 'topical anesthesia Intranasal Mucosal Atomization', 'type': 'DEVICE', 'otherNames': ['single-use product (LMA® MAD Nasal™ Intranasal Mucosal Atomization Device, Teleflex medical, Kernen Germany) for topical anesthesia'], 'armGroupLabels': ['topical anesthesia Intranasal Mucosal Atomization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Dep. Respiratory Medicine, Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Thomas Fuehner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}