Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT04533334
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2020-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measurement of the Distances of the Lower Airway in Pediatric Population
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': 299}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-01', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper/Lower Airway Ratio', 'timeFrame': '1 day', 'description': 'Ratio of the distance between labium oris to carina and carina to right upper lobe orifice'}], 'secondaryOutcomes': [{'measure': 'Correlation between patient characteristics and distances measured by FOB', 'timeFrame': '1 day', 'description': 'Correlation between age, body mass index, gender, percentiles and the distance between labium oris to carina and carina to right upper lobe orifice'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia', 'fiberoptic bronchoscopy', 'lower airway anatomy', 'child', 'right upper lobe bronchus'], 'conditions': ['Airway', 'Child', 'Bronchus']}, 'referencesModule': {'references': [{'pmid': '19654121', 'type': 'BACKGROUND', 'citation': 'Rudraraju P, Eisen LA. Confirmation of endotracheal tube position: a narrative review. J Intensive Care Med. 2009 Sep-Oct;24(5):283-92. doi: 10.1177/0885066609340501. Epub 2009 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative atelectasis and even mortality.\n\nIn this study, investigators will measure the distance between distal margin of right lung upper lobe orifice-carina and carina-lip with the help of fiberoptic bronchoscopy (FOB).', 'detailedDescription': 'In ASA-PS I-II-III children between 1-18 years of age who are orotracheally intubated for any reason, the fiber optic bronchoscope will be advanced in the tube and first the carina distance and then the carina to right upper bronchus distance will be measured.\n\nAge, weight, height, body mass index (BMI), weight percentile, height percentile, comorbidities, ASA score, tube size, lip margin distance, right upper bronchus to carina distance and right upper lobe to carina distance/ Carina to-lip margin ratio will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing general anesthesia via an endotracheal tube will be eligible for recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing general anesthesia via an endotracheal tube\n* ASA I-III\n\nExclusion Criteria:\n\n* Patients that do not meet age criteria\n* Uncontrolled asthma or hyper reactive airway\n* hypoxemia, previous thoracic surgery\n* ASA \\> III\n* Unstable hemodynamics\n* Patients with tracheal or oral malignancies\n* Patients with face trauma\n* Informed consent not given\n* using a tube with a number too small for the fiberoptic bronchoscope to pass through'}, 'identificationModule': {'nctId': 'NCT04533334', 'briefTitle': 'Measurement of the Distances of the Lower Airway in Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Measurement of the Distance Between the Orifice of the Right Upper Lobe and Carinae and Labium Oris With Fiberoptic Bronchoscopy in Pediatric Population in Turkey', 'orgStudyIdInfo': {'id': '26082020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric', 'description': 'FOB measurement of the distance between carina and right upper lobe bronchus and carina and labium oris in pediatric population', 'interventionNames': ['Procedure: FOB measurement']}], 'interventions': [{'name': 'FOB measurement', 'type': 'PROCEDURE', 'description': 'A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.', 'armGroupLabels': ['Pediatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University-Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'PINAR Kendigelen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University - Cerrahpasa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data available on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kadir Melih YILMAZ', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}