Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-18 @ 4:12 PM
Study NCT ID:
NCT01995292
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2013-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020680', 'term': 'Bronchoscopes'}], 'ancestors': [{'id': 'D019723', 'term': 'Endoscopes'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort evaluation by the patient', 'timeFrame': 'up to 4 weeks', 'description': 'Comparison of conventional and modified "spray as you go" technique'}], 'secondaryOutcomes': [{'measure': 'Comfort evaluation by the performing as well as assisting anesthetist', 'timeFrame': 'up to 4 weeks', 'description': 'Comparison of conventional and modified "spray as you go" technique'}, {'measure': 'Comfort evaluation by the present nurses', 'timeFrame': 'up to 4 weeks', 'description': 'Comparison of conventional and modified "spray as you go" technique'}, {'measure': 'Patient response (coughing, gagging, grimacing, defenses)', 'timeFrame': 'up to 4 weeks', 'description': 'Comparison of conventional and modified "spray as you go" technique'}, {'measure': 'Vital signs', 'timeFrame': 'up to 4 weeks', 'description': 'Comparison of conventional and modified "spray as you go" technique'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['awake fiberoptic intubation', 'spray as you go technique', 'anesthesia', 'Enk Fiberoptic Atomizer Set'], 'conditions': ['Awake Fiberoptic Intubation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether modified "spray as you go" technique using the Enk Fiberoptic Atomizer Set during awake fiberoptic intubation is more comfortable for the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* no concurrent participation in another clinical trial\n* German language in speaking and writing\n* Capability of giving consent\n* written informed consent\n* an elective surgery under general anesthesia, in which an awake fiberoptic intubation is indicated\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* pregnant women\n* patients unwilling or unable to give informed consent\n* ASA classification \\> 3\n* Known allergy to local anesthetics\n* Participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT01995292', 'briefTitle': 'Comparison of Two Different Types of "Spray as You go" Technique for Awake Fiberoptic Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Comparative Clinical Trial of Conventional and Modified "Spray as You go" Technique With the "Enk Fiberoptic Atomizer Set" for Awake Fiberoptic Intubation (Atomizer Study)', 'orgStudyIdInfo': {'id': 'Atomizer1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bronchoscope', 'description': 'Patients will receive local anaesthetics via the working channel of the bronchoscope.', 'interventionNames': ['Device: bronchoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Enk Fiberoptic Atomizer', 'description': 'Patients will receive local anaesthetics for the awake fiberoptic intubation via the Enk Fiberoptic Atomizer.', 'interventionNames': ['Device: Enk Fiberoptic Atomizer']}], 'interventions': [{'name': 'bronchoscope', 'type': 'DEVICE', 'otherNames': ['Standard procedure: Instillation of local anesthetics via the working channel of the bronchoscope'], 'armGroupLabels': ['bronchoscope']}, {'name': 'Enk Fiberoptic Atomizer', 'type': 'DEVICE', 'otherNames': ['Nebulization of local anesthetics with the Enk Fiberoptic Atomizer during awake fiberoptic intubation'], 'armGroupLabels': ['Enk Fiberoptic Atomizer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Johannes Gutenberg - Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Nina Pirlich', 'investigatorFullName': 'Nina Pirlich, Dr. med.', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}