Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-28 @ 9:11 PM
Study NCT ID:
NCT03560895
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2018-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US Prediction of Actual Tube Size and Performance Characteristics of Pediatric Cuffed Vs Un-Cuffed ETT.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-22', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-06-15', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT', 'timeFrame': 'AT induction of anesthesia', 'description': 'The rate of agreement between the reference tube size based on sonographic measurements and the final BEST-FIT ETT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Complication of Anesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to test the accuracy of Sonography in determining the endotracheal tube size in pediatric patients whether cuffed or un-cuffed.', 'detailedDescription': "* Children's tracheas have traditionally been intubated with un-cuffed tracheal tubes (TT) due to differences between adult and pediatric sub-glottic anatomy and fears that cuffs may lead to mucosal damage and subglottic stenosis. Despite this, cuffed TTs are increasingly used in pediatric anesthesia. Over the last 20 years, evidence suggests that cuffed TT may have advantages over un-cuffed, and are associated with at least similar, if not superior, airway outcomes when compared with un-cuffed TT in children.\n* Formulas based on age and height often fail to reliably predict the proper endotracheal tube (ETT) size in pediatric patients. Visualization of the pediatric subglottic airway diameter by ultrasonography (USG) can enable a practitioner to better predict ETT size, preventing unnecessary tube changes and airway trauma. Also, Visualization of the transvers diameter of epiphyseal end of distal radius by ultrasonography (USG) has been recently investigated and can enable a practitioner to better predict ETT size. Recent reports suggest that the diameter of the subglottic upper airway can be determined by ultrasonography in healthy young adults and pediatric patients . However, the extent to which ultrasonography by these two measurements can predict optimal ETT size in pediatric patients remains under investigation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 1-6 years of both sexes undergoing surgical procedures in which an endotracheal tube is needed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight: 10-30 kg.\n* Age: 1-6 years.\n* Sex: both males and females.\n* ASA physical status: I-II.\n* Operation: elective surgery in which airway management with an endotracheal tube is needed.\n\nExclusion Criteria:\n\n* Upper airway malformations.\n* Upper airway surgery.\n* Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,\n* Anticipated difficult airway.'}, 'identificationModule': {'nctId': 'NCT03560895', 'acronym': 'USETT', 'briefTitle': 'US Prediction of Actual Tube Size and Performance Characteristics of Pediatric Cuffed Vs Un-Cuffed ETT.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasonographic Prediction of Actual Tube Size and Performance Characteristics of Cuffed Vs Un-Cuffed Endotracheal Tubes in Pediatric Surgical Patients.', 'orgStudyIdInfo': {'id': '17200201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube (Flexicare-UK) ) with its outer diameter determined by ultrasonography.', 'interventionNames': ['Device: cuffed endotracheal tube']}, {'label': 'Group II', 'description': 'Patients will be anesthetized using uncuffed endotracheal tube (Flexicare-UK) with its outer diameter determined by ultrasonography.', 'interventionNames': ['Device: Uncuffed endotracheal tube']}], 'interventions': [{'name': 'cuffed endotracheal tube', 'type': 'DEVICE', 'otherNames': ['C ETT'], 'description': 'Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube', 'armGroupLabels': ['Group I']}, {'name': 'Uncuffed endotracheal tube', 'type': 'DEVICE', 'otherNames': ['ETT'], 'description': 'Patients will be anesthetized using uncuffed endotracheal tube', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '715715', 'city': 'Asyut', 'state': 'Assiut Governorate', 'country': 'Egypt', 'facility': 'Pediatric hospital, faculty of medicine, Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Hala S Abdelghaffar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of anesthesia, faculty of medicine, Assiut university, Egypt.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of anesthesia and intensive care, faculty of medicine, Assiut university.', 'investigatorFullName': 'Hala Saad Abdel-Ghaffar', 'investigatorAffiliation': 'Assiut University'}}}}