Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-05 @ 7:04 PM
Study NCT ID:
NCT03838705
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2019-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2019-02-10', 'studyFirstSubmitQcDate': '2019-02-10', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SpO2', 'timeFrame': '48 hours', 'description': 'Peripheral Oxygen Saturation'}], 'secondaryOutcomes': [{'measure': 'STOP-BANG', 'timeFrame': 'preoperative 24 hours', 'description': 'The value of STOP-BANG questionnaire'}, {'measure': '4-V Tool', 'timeFrame': 'preoperative 24 hours', 'description': 'The value of 4-V Tool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stop-bang, bariatric surgery, obesity, hypoxia'], 'conditions': ['Hypoxia', 'Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'In our study, we aimed to investigate the relationship between STOP-BANG and 4-Variable Screening questionnaires in postoperative period in patients who underwent bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>40\n* bariatric surgery patients\n\nExclusion Criteria:\n\n* malignancy\n* patients who are unable to complete the questionnaire\n* patients who needs laparotomy'}, 'identificationModule': {'nctId': 'NCT03838705', 'briefTitle': 'The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'The Relationship Between Postoperative Oxygenation and STOP-BANG Questionnaire and 4-V Tool in Preoperative Bariatric Surgery Patients', 'orgStudyIdInfo': {'id': 'SS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'bariatric surgery patients', 'description': 'patients aged 18-65 years with ASA status II-III, BMI\\>40 who were undergoing bariatric surgery operation', 'interventionNames': ['Procedure: hypoxia', 'Procedure: normooxy']}], 'interventions': [{'name': 'hypoxia', 'type': 'PROCEDURE', 'description': 'It was accepted that hypoxia developed in patients with SpO2\\< 92 or falling over 20% compared to preoperative values.', 'armGroupLabels': ['bariatric surgery patients']}, {'name': 'normooxy', 'type': 'PROCEDURE', 'description': 'It was accepted that patients with SpO2 between 100-92 mmHg', 'armGroupLabels': ['bariatric surgery patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Umraniye Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Sibel O Serin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Umraniye Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sibel Ocak Serin', 'class': 'UNKNOWN'}, {'name': 'Aysun Isiklar', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Gulsah Karaoren', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}