Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT03044418
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2017-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anesthesia With Endotracheal Laser Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'timokeri@gmail.com', 'phone': '+36 72 507374', 'title': 'Dr. Timea Bocskai', 'organization': 'University of Pecs'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The special laser tube is used only for less than one hour'}}, 'adverseEventsModule': {'timeFrame': '6 months; between January 2017 and June 2017 during our study', 'eventGroups': [{'id': 'EG000', 'title': 'The Frequency of Side Effects of Special ET Laser Tube Using', 'description': 'The frequency of side effects of anesthesia with special ET laser tube are analysed during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We tested the application of ET laser tube in propofol anesthesia.\n\nThe special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia With Laser Tube', 'description': 'the side effects of anesthesia with a special ET laser tube'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 months', 'description': 'problem with airway or special laser tube', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anesthesia With Special ET Laser Tube', 'description': 'The special ET laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We test the application of ET laser tube in propofol anesthesia.\n\nThe special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'The Side Effects of Anesthesia With Special ET Laser Tube', 'description': 'The frequency of side effects of anesthesia with a special ET laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We test the application of ET laser tube in propofol anesthesia.\n\nThe special endotracheal laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'adults over 18 years', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'European', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Etnicity of patients was European.', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2016-12-06', 'size': 161760, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-08-26T08:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '5 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2017-01-29', 'resultsFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-24', 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Side Effects', 'timeFrame': '5 months', 'description': 'problem with airway or special laser tube'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laser', 'endotracheal tube', 'total intravenous anesthesia', 'side effect', 'endolaryngeal surgery'], 'conditions': ['Anesthesia', 'Anesthesia Morbidity']}, 'descriptionModule': {'briefSummary': 'The study examines the special endotracheal laser tube during anesthesia of endolaryngeal laser surgery.', 'detailedDescription': 'The special endotracheal tube is covered by a special aluminum tape.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with endolaryngeal laser surgery and after 18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laser surgery\n\nExclusion Criteria:\n\n* allergy of propofol'}, 'identificationModule': {'nctId': 'NCT03044418', 'briefTitle': 'Anesthesia With Endotracheal Laser Tube', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Anesthesia of Endolaryngeal Surgery With a Special Endotracheal Laser Tube', 'orgStudyIdInfo': {'id': '6419'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anesthesia with laser tube', 'description': 'The special endotracheal (ET) laser tube is tested during endolaryngeal laser surgery. Anesthesia type is the total intravenous anesthesia with propofol. We tested the application of ET laser tube in propofol anesthesia.', 'interventionNames': ['Other: Application of ET laser tube in propofol anesthesia']}], 'interventions': [{'name': 'Application of ET laser tube in propofol anesthesia', 'type': 'OTHER', 'description': 'The special ET laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.', 'armGroupLabels': ['anesthesia with laser tube']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pécs', 'country': 'Hungary', 'facility': 'PTE Department of ENT', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}], 'overallOfficials': [{'name': 'Lajos Bogar, MedHabil', 'role': 'STUDY_CHAIR', 'affiliation': 'PTE Department of the Anesthesiology and Intensive Therapy'}, {'name': 'Laszlo Lujber, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'PTE Department of ENT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Timea Bocskai', 'investigatorAffiliation': 'University of Pecs'}}}}