Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-18 @ 2:06 PM
Study NCT ID:
NCT02321956
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sealed envelops were used. Ultrasonographers were masked with the group of patients. Participants were masked with the techniques of selecting endotracheal tubes. Care providers and outcome assessors were masked with the techniques of selecting. endotracheal tubes'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-04', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proper size of endotracheal tube', 'timeFrame': '1 year', 'description': 'Clinically fit of endotracheal tube with leak at 20-25 cmH2O'}], 'secondaryOutcomes': [{'measure': 'Correlation of subglottic diameter and proper size endotracheal tube', 'timeFrame': '1 year', 'description': 'Correlation of subglottic diameter measured by ultrasound and proper size endotracheal tube determined by clinically fit.'}]}, 'conditionsModule': {'keywords': ['ASA class 1,2', 'age 1-6 years', 'General anesthesia with ETT'], 'conditions': ['Pediatric General Anesthesia With Endotracheal Tube']}, 'referencesModule': {'references': [{'pmid': '20808208', 'type': 'BACKGROUND', 'citation': 'Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula', 'detailedDescription': 'This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-6 Years\n* ASA class 1-2\n* Elective Surgery\n* GA with oral uncuff endotracheal tube\n\nExclusion Criteria:\n\n* Potential difficult air way from history and physical exam\n* Allergy ti ultrasound gel\n* neck mass\n* unstable vital sign'}, 'identificationModule': {'nctId': 'NCT02321956', 'briefTitle': 'Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients', 'orgStudyIdInfo': {'id': 'RAti-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound', 'description': 'Using ultrasound measurement of the subglottic area to choose endotracheal tube size', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'Formula', 'description': "Using Cole's formula to choose endotracheal tube size"}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Using ultrasound to determine the size of endotracheal tube', 'armGroupLabels': ['Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkoknoi', 'country': 'Thailand', 'facility': 'Raviwon Atisook', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Raviwon Atisook', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of anesthesiology siriraj hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of anesthesiology', 'investigatorFullName': 'Raviwon Atisook', 'investigatorAffiliation': 'Siriraj Hospital'}}}}