Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-05 @ 8:00 PM
Study NCT ID:
NCT07303205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Postoperative Hypoxemia', 'timeFrame': 'Postoperative 0-12 hours', 'description': 'Hypoxemia defined as SpO₂ \\< 92% or new oxygen requirement within the first postoperative hours.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '41188672', 'type': 'RESULT', 'citation': 'Helmy MA, Mostafa MS, Saber AT, Ali MA, Milad LM. Erector Spinae Plane Block and its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy: A Double-Blind Randomized Control Trial. Obes Surg. 2025 Nov 4. doi: 10.1007/s11695-025-08337-y. Online ahead of print.'}, {'pmid': '38941098', 'type': 'RESULT', 'citation': 'Wang X, Guo K, Sun J, Yang Y, Wu Y, Tang X, Xu Y, Chen Q, Zeng S, Wang L, Liu S. Semirecumbent Positioning During Anesthesia Recovery and Postoperative Hypoxemia: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2416797. doi: 10.1001/jamanetworkopen.2024.16797.'}, {'pmid': '40468628', 'type': 'RESULT', 'citation': 'Lee S, Hong H, Cho H, Lee SW, You AH, Kang HY, Park SW, Kim MK, Choi JH. Association between preoperative oxygen reserve index and postoperative pulmonary complications: a prospective observational study. Korean J Anesthesiol. 2025 Jun;78(3):224-235. doi: 10.4097/kja.24420. Epub 2025 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study evaluates whether the preoperative ROX index can predict early postoperative hypoxemia in patients undergoing bariatric surgery. Preoperative ROX measurements, along with ARISCAT and STOP-Bang scores, will be assessed for their association with hypoxemia occurring within the first 12 postoperative hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients scheduled for elective bariatric surgery, including laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. All participants are obese (BMI ≥ 35 kg/m²) and evaluated preoperatively in the anesthesia clinic prior to surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Scheduled for elective bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass)\n* Body mass index (BMI) ≥ 35 kg/m²\n* ASA physical status I-III\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Acute respiratory failure, pneumonia, or active pulmonary infection\n* Receiving oxygen therapy or respiratory support (nasal cannula, CPAP, BiPAP, or high-flow oxygen) preoperatively\n* Preoperative SpO₂ \\< 88% on room air\n* Significant cardiac arrhythmia, severe heart failure (NYHA class III-IV), or hemodynamic instability\n* Pregnancy, active malignancy, or current immunosuppressive therapy\n* Inability to complete postoperative follow-up or early discharge before 12-hour assessment'}, 'identificationModule': {'nctId': 'NCT07303205', 'briefTitle': 'Preoperative ROX Index and Postoperative Hypoxemia in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Predictive Value of the Preoperative ROX Index for Early Postoperative Hypoxemia in Bariatric Surgery Patients: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'erkan rox indeksi'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Preoperative ROX Index Assessment', 'type': 'OTHER', 'description': 'Participants will undergo a preoperative assessment including measurement of the ROX index (SpO₂/FiO₂ divided by respiratory rate) before bariatric surgery. No treatment or study-related intervention will be applied; all perioperative care will follow routine clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'state': 'Merkez Mahallesi', 'country': 'Turkey (Türkiye)', 'facility': 'Istinye Üniversity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ilke dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof', 'investigatorFullName': 'İlke Dolgun', 'investigatorAffiliation': 'Istinye University'}}}}