Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-01 @ 1:55 PM
Study NCT ID:
NCT01100957
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2010-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2010-03-25', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time for completion of intubation', 'timeFrame': 'September 2010', 'description': 'This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study'}], 'secondaryOutcomes': [{'measure': 'time for preparing and cleaning the endoscopes', 'timeFrame': 'september 2010', 'description': 'this is measured in the hour before and after the intubation'}, {'measure': 'number of intubation attempts', 'timeFrame': 'september 2010', 'description': 'measured during the intubation'}, {'measure': 'success rate of endotracheal intubation', 'timeFrame': 'september 2010', 'description': 'measured during the intubation'}, {'measure': 'total time for the intubation-procedure inclusive the time for distributing local analgesics', 'timeFrame': 'september 2010', 'description': 'measured during the intubation'}, {'measure': 'Quality of the image from the videoscope', 'timeFrame': 'september 2010', 'description': 'Observed immediately before, and during, the intubation'}, {'measure': 'Evaluation of the insertion cord of the flexible scope', 'timeFrame': 'september 2010', 'description': 'measured during the intubation'}, {'measure': 'Evaluation of the working-/-injection-channel', 'timeFrame': 'september 2010', 'description': 'measured during the intubation'}]}, 'conditionsModule': {'conditions': ['Tracheal Intubation', 'Difficult Airway']}, 'descriptionModule': {'briefSummary': 'The study is in two parts\n\nPart one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.\n\nPart two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.\n\nThe hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Study part 1:\n\n * Patients scheduled for tracheal intubation and predicted to have a normal airway\n * ASA class I, II or III\n * \\>18 years\n2. Study part 2:\n\n * Adult patients scheduled for tracheal intubation and predicted to have a difficult airway\n * ASA class I, II or III\n * \\>18 years\n\nExclusion Criteria:\n\n1. Study part 1:\n\n * Massive bleeding from the mouth\n * Previously abandoned flexible optical intubation\n2. Study part 2:\n\n * Massive bleeding from the mouth\n * Previously abandoned flexible optical intubation\n * Patients with audible stridor\n * Patients with dyspnea'}, 'identificationModule': {'nctId': 'NCT01100957', 'briefTitle': 'Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': "Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway", 'orgStudyIdInfo': {'id': 'aScope-1+2 a'}, 'secondaryIdInfos': [{'id': 'H-A-2009-022'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional flexible videoscope for intubation', 'interventionNames': ['Procedure: tracheal intubation with a single use flexible videoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Single-patient flexible endoscope', 'description': 'Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm', 'interventionNames': ['Procedure: tracheal intubation with a single use flexible videoscope']}], 'interventions': [{'name': 'tracheal intubation with a single use flexible videoscope', 'type': 'PROCEDURE', 'description': 'tracheal intubation with a single use flexible videoscope', 'armGroupLabels': ['Conventional flexible videoscope for intubation', 'Single-patient flexible endoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Michael S Kristensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Michael Seltz Kristensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}