Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04686656
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypoxia-related interruptions', 'timeFrame': '30 minutes', 'description': 'the number of hypoxia-related interruptions'}], 'secondaryOutcomes': [{'measure': 'duration of procedure', 'timeFrame': '30 minutes', 'description': 'Duration of procedure will be defined in minute as the time from starting to insert EBUS device until the time to remove the device'}, {'measure': 'use of propofol', 'timeFrame': '30 minutes', 'description': 'The use of amount of propofol will be noted during the procedure.'}, {'measure': 'use of fentanyl', 'timeFrame': '30 minutes', 'description': 'The use of amount of fentanyl will be noted during the procedure.'}, {'measure': 'satisfaction of pulmonary specialist', 'timeFrame': '30 minutes', 'description': 'satisfaction of pulmonary specialist will be evaluated by 4-points Likert Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .', 'detailedDescription': 'Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients ≥18 years of age\n* body mass index (BMI) between 20 and 30\n* American Society of Anesthesiologists physical status I-III\n\nExclusion Criteria:\n\n* congestive heart failure\n* ischemic heart disease\n* increased intracranial pressure\n* known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)\n* an anatomical feature precluding adequate positioning of the buccal device.'}, 'identificationModule': {'nctId': 'NCT04686656', 'briefTitle': 'Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration', 'orgStudyIdInfo': {'id': 'tayfun1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nasal oxygen supplementation group', 'description': 'supplemental oxygen will be administered with nasal cannula', 'interventionNames': ['Other: nasal oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'buccal oxygen supplementation group', 'description': 'supplemental oxygen will be administered with Ring-Adair-Elwyn (RAE) tube', 'interventionNames': ['Other: buccal oxygen']}], 'interventions': [{'name': 'nasal oxygen', 'type': 'OTHER', 'description': 'Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.', 'armGroupLabels': ['nasal oxygen supplementation group']}, {'name': 'buccal oxygen', 'type': 'OTHER', 'description': 'Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.', 'armGroupLabels': ['buccal oxygen supplementation group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Training and Researching Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'tayfun sugur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}