Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT03462732
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2018-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2018-02-24', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence and severity of Epistaxis', 'timeFrame': 'immediately after nasotracheal intubation', 'description': 'An independent anesthesiologist who did not observe the tube insertion will assess the incidence and severity of epistaxis using a laryngoscope immediately after tube passage through the nasal cavity , four grades to evaluate epistaxis 1- no epistaxis 2- mild epistaxis ,blood apparent on the surface of the tube 3-moderate epistaxis pooling of blood on the posterior pharyngeal wall 4- severe epistaxis , large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation.'}], 'secondaryOutcomes': [{'measure': 'Histopathology of the endotracheal tube contents after extubation', 'timeFrame': 'immediately after extubation', 'description': 'after extubation the tube contents will be collected in a 5 ml syringe by using sterile swab then tissues will be separated and will be sent for histopathology , the remnant contents will be sent for microscopy , grading the contents as follow 1- secretions only 2- secretions plus blood 3- secretions , blood plus tissues .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years\n* physical status American society of Anesthesiologist(ASA) I orII\n\nExclusion Criteria:\n\n* History of recurrent epistaxis\n* Coagulopathy\n* Previous nasal surgery\n* History of nasal trauma\n* Severe renal , hepatic or cardiovascular disease\n* History of drug allergy to the drugs used in the study'}, 'identificationModule': {'nctId': 'NCT03462732', 'briefTitle': 'Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FAMSU R 6 / 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Endotracheal tube plus Nelaton catheter', 'interventionNames': ['Device: Endotracheal tube', 'Device: Nelaton catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Endotracheal tube', 'interventionNames': ['Device: Endotracheal tube']}], 'interventions': [{'name': 'Endotracheal tube', 'type': 'DEVICE', 'description': 'Nasotracheal intubation will be done with endotracheal tube', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Nelaton catheter', 'type': 'DEVICE', 'otherNames': ['Stent'], 'description': 'plus nelaton catheter', 'armGroupLabels': ['Group I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amin Mohammed Alansary Amin Ahmed Helwa', 'investigatorAffiliation': 'Ain Shams University'}}}}