Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT02517294
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Katrin.Post-Martens@nemours.org', 'phone': '904-330-9942', 'title': 'Dr Katrin Post-Martens', 'organization': 'Nemours'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'day of procedure, up to 12 hours', 'description': 'the study did not include experimental equipment or a deviation from the standard of care', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size", 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size", 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'OG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within approximately 4hrs of surgery (day of surgery)', 'description': 'Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Nasotracheal Tube Impingement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'OG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'perioperative, immediate during intervention - expected 2hrs (day of surgery)', 'description': 'Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Epistaxis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'OG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants will be followed for the duration of the hospital stay, an expected average of 6 hours', 'description': 'ongoing nasal bleeding in the recovery unit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Croup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'OG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'end of surgery until time of discharge, approximately 4hrs', 'description': 'evidence of glottic edema/injury in the immediate postoperative time frame', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Discharge in Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'OG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'emergence from anesthesia to meeting discharge criteria, approximately 4hrs', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'FG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Nasotracheal Tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes\n\nStandard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'BG001', 'title': 'Parker Flex-tip Nasotracheal Tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes\n\nParker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.13', 'spread': '1.98', 'groupId': 'BG000'}, {'value': '6.43', 'spread': '2.20', 'groupId': 'BG001'}, {'value': '6.27', 'spread': '2.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '3.33', 'groupId': 'BG000'}, {'value': '16.9', 'spread': '4.46', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '3.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-10', 'size': 220345, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-06T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2015-05-22', 'resultsFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-23', 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Epistaxis', 'timeFrame': 'within approximately 4hrs of surgery (day of surgery)', 'description': 'Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Nasotracheal Tube Impingement', 'timeFrame': 'perioperative, immediate during intervention - expected 2hrs (day of surgery)', 'description': 'Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation'}, {'measure': 'Number of Participants With Postoperative Epistaxis', 'timeFrame': 'Participants will be followed for the duration of the hospital stay, an expected average of 6 hours', 'description': 'ongoing nasal bleeding in the recovery unit'}, {'measure': 'Number of Participants With Postoperative Croup', 'timeFrame': 'end of surgery until time of discharge, approximately 4hrs', 'description': 'evidence of glottic edema/injury in the immediate postoperative time frame'}, {'measure': 'Time to Discharge in Minutes', 'timeFrame': 'emergence from anesthesia to meeting discharge criteria, approximately 4hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nasotracheal intubation', 'adenoid size', 'epistaxis', 'nasopharyngeal mucosal injury'], 'conditions': ['Epistaxis']}, 'descriptionModule': {'briefSummary': 'Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.', 'detailedDescription': 'The Parker flex-tip, midline-beveled nasotracheal tube theoretically slides past obstruction in the nasopharynx causing less mucosal damage than standard nasotracheal tubes.\n\nThe investigators aim to test whether mucosal injury during nasotracheal intubation in children undergoing general anesthesia for dental procedures can thus be minimized taking into consideration adenoid size, and differences in nasopharyngeal diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children between the ages of 3-11, ASA 1-3, presenting to Wolfson Children's Hospital (WCH) for dental procedures requiring general anesthesia with nasotracheal intubation.\n\nExclusion Criteria:\n\n* ASA \\>3\n* known bleeding disorders\n* recent or ongoing treatment with blood-thinning medicines\n* frequent epistaxis\n* active URI/congestion/rhinorrhea\n* craniofacial abnormalities prohibiting NTI\n* known difficult airway\n* prior nasal surgery/trauma\n* allergies to any of the medicines used in this study."}, 'identificationModule': {'nctId': 'NCT02517294', 'briefTitle': ', "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': '"Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"', 'orgStudyIdInfo': {'id': '#15-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard nasotracheal tube', 'description': "Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes", 'interventionNames': ['Device: Standard nasotracheal tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parker flex-tip nasotracheal tube', 'description': "Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes", 'interventionNames': ['Device: Parker flex-tip nasotracheal tube']}], 'interventions': [{'name': 'Parker flex-tip nasotracheal tube', 'type': 'DEVICE', 'description': 'specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size', 'armGroupLabels': ['Parker flex-tip nasotracheal tube']}, {'name': 'Standard nasotracheal tube', 'type': 'DEVICE', 'description': 'standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size', 'armGroupLabels': ['standard nasotracheal tube']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Wolfson Children's Hospital", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Robert B Bryskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Clinic, Jacksonville, FL"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}