Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT01095861
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2009-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2009-09-02', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sore throat', 'timeFrame': '48-72 hours', 'description': 'Patients fill in a questionaire 48-72 hours after Surgery by a blinded data assessor.\n\nThey are asked if they had a sore throat after their surgery. If so, they are asked to grade the sore throat as mild, moderate, or severe, when it was at its worst.\n\nNote: There is only one questionaire for both outcomes.'}], 'secondaryOutcomes': [{'measure': 'Vocal changes', 'timeFrame': '48-72 hours', 'description': 'Patients fill in a questionaire 48-72 hours after Surgery by a blinded data assessor.\n\nThey are asked if they had vocal changes after their surgery. If so, they are asked to grade the vocal changes as mild, moderate, or severe, when the changes were at its worst. Patients are asked for one word to best characterise the vocal changes.\n\nNote: There is only one questionaire for both outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endotracheal tube'], 'conditions': ['Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '22057874', 'type': 'DERIVED', 'citation': 'Turkstra TP, Smitheram AK, Alabdulhadi O, Youssef H, Jones PM. The Flex-Tip tracheal tube does not reduce the incidence of postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 Dec;58(12):1090-6. doi: 10.1007/s12630-011-9592-5. Epub 2011 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).', 'detailedDescription': 'The post-operative complication of a sore throat after endotracheal intubation is unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of 35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore throat and/or vocal changes unless directly asked because surgical pain is more prominent and many patients may be unaware that intubation completed as part of the general anesthetic. (Harding 1987)\n\nThe Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino 2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of sore throat was not examined. (Kristensen 2003)\n\nOur previous study (Jones 2007) demonstrated that modification of anesthetic techniques could reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the incidence of sore throat in patients undergoing oro-tracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient scheduled for elective surgery.\n* ETT is indicated for the procedure in the opinion of the attending anesthesiologist.\n\nExclusion Criteria:\n\n* Any patients with known or probable difficult airways.\n* Any patient requiring rapid sequence induction.'}, 'identificationModule': {'nctId': 'NCT01095861', 'briefTitle': 'Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'R-09-126'}, 'secondaryIdInfos': [{'id': '16016', 'type': 'OTHER', 'domain': 'REB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FlexTip ETT', 'description': 'FlexTip ETT', 'interventionNames': ['Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard Flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube Catalog # 86114 Mallinckrodt, ST. Louis, MO, 63134', 'interventionNames': ['Device: Control - standard flexible ETT (Mallinckrodt)']}], 'interventions': [{'name': 'FlexTip ETT (Parker FlexTip/GlideScope FlexTip)', 'type': 'DEVICE', 'otherNames': ['Parker FlexTip', 'GlideScope FlexTip'], 'description': 'FlexTip ETT used for endotracheal intubation', 'armGroupLabels': ['FlexTip ETT']}, {'name': 'Control - standard flexible ETT (Mallinckrodt)', 'type': 'DEVICE', 'description': 'Control - standard flexible ETT\n\nMallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Timothy P Turkstra, MD, M. Eng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}, {'name': 'Philip M Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Timothy P Turkstra', 'oldOrganization': 'University of Western Ontario'}}}}