Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT00953433
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2009-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2009-08-05', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative hoarseness', 'timeFrame': '1 hr postoperatively'}], 'secondaryOutcomes': [{'measure': 'Vocal cord sequelae', 'timeFrame': 'Preoperative - on average 12 hours before operation'}, {'measure': 'Intubation conditions', 'timeFrame': 'During and after intubation - on average 5 minutes'}, {'measure': 'Intubation difficulty scale', 'timeFrame': 'During and after intubation - on average 5 minutes'}, {'measure': 'Voice Range Profile', 'timeFrame': '72 hours postoperatively', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Multi Dimensional Voice Profile', 'timeFrame': 'Preoperative - on average 12 hours before operation'}, {'measure': 'Voice Handicap Index', 'timeFrame': 'Preoperative - on average 12 hours before operation'}, {'measure': 'Voice Range Profile', 'timeFrame': 'After 4 weeks', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Vocal cord sequelae', 'timeFrame': 'Within 24 hr postoperatively'}, {'measure': 'Vocal cord sequelae', 'timeFrame': '72 hours postoperatively', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Vocal cord sequelae', 'timeFrame': 'After 4 weeks', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Multi Dimensional Voice Profile', 'timeFrame': 'Within 24 hr postoperatively'}, {'measure': 'Multi Dimensional Voice Profile', 'timeFrame': '72 hours postoperatively', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Multi Dimensional Voice Profile', 'timeFrame': 'After 4 weeks', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Voice Handicap Index', 'timeFrame': 'After 4 weeks', 'description': 'Only for the subgroup of patients with persisting hoarseness'}, {'measure': 'Voice Handicap Index', 'timeFrame': '72 hr postoperatively', 'description': 'Only for the subgroup of patients with persisting hoarseness'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intratracheal'], 'conditions': ['Intubation Complication', 'Anaesthesia']}, 'descriptionModule': {'briefSummary': 'This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.\n\nStudy hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgical patients who require an endotracheal tube during general anaesthesia.\n* Informed consent.\n* Legally competent.\n* Be able to understand Danish and be able to read the given information in Danish.\n\nExclusion Criteria:\n\n* Planned or former operation in or around the pharynx or the larynx.\n* Cancer, infection or sequelae in or around the pharynx or the larynx.\n* Use of a stomach tube before or during surgery.\n* Suspected difficult intubation.'}, 'identificationModule': {'nctId': 'NCT00953433', 'briefTitle': 'Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet', 'orgStudyIdInfo': {'id': 'Endoflex-Stylet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoflex tube', 'description': 'Use of Endoflex tube for intubation.', 'interventionNames': ['Device: Endoflex tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endotracheal tube with stylet', 'description': 'Use of conventional endotracheal tube with a stylet for intubation.', 'interventionNames': ['Device: Polyvinyl chloride endotracheal tube with a stylet']}], 'interventions': [{'name': 'Endoflex tube', 'type': 'DEVICE', 'description': 'Size decided upon gender.', 'armGroupLabels': ['Endoflex tube']}, {'name': 'Polyvinyl chloride endotracheal tube with a stylet', 'type': 'DEVICE', 'description': 'Size decided upon gender.', 'armGroupLabels': ['Endotracheal tube with stylet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars Rasmussen, MD, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'TrygFonden, Denmark', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Martin Kryspin Soerensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}