Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07344103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Postoperative Hypoxemia', 'timeFrame': 'Within the first 30 minutes after admission to the post-anesthesia care unit (PACU)', 'description': 'Early postoperative hypoxemia will be defined as an oxygen saturation (SpO₂) below 92% or the requirement for supplemental oxygen at a flow rate of 4 L/min or higher.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '39027799', 'type': 'BACKGROUND', 'citation': "Khurshied S, Zahid MA, Babar A, Rafique MH, Khurshid N, Hussain A, Saif M. Effects of Nasal Packing on Patients' Post-operative Vital Signs. Cureus. 2024 Jun 18;16(6):e62616. doi: 10.7759/cureus.62616. eCollection 2024 Jun."}, {'pmid': '39544775', 'type': 'BACKGROUND', 'citation': 'Xiong N, Nong Y, Yi Y. Meta-analysis of risk factors associated with postoperative hypoxemia in the postanesthesia care unit. Am J Transl Res. 2024 Oct 15;16(10):5787-5796. doi: 10.62347/LCKG5157. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Early postoperative hypoxemia is a frequent complication after elective ear, nose, and throat (ENT) surgery and may adversely affect recovery in the post-anesthesia care unit (PACU). Simple and non-invasive preoperative tools to identify patients at risk for early postoperative hypoxemia are limited.\n\nThe ROX index, calculated using oxygen saturation, fraction of inspired oxygen, and respiratory rate, is an easily applicable bedside parameter that has been shown to predict respiratory deterioration in various clinical settings. However, its predictive value in the preoperative period for patients undergoing elective ENT surgery has not been well established.\n\nThis prospective observational study aims to evaluate the association between the preoperative ROX index measured on room air and early postoperative hypoxemia in adult patients undergoing elective septorhinoplasty or endoscopic sinus surgery under general anesthesia. Early postoperative hypoxemia will be defined as oxygen saturation below 92% or the need for supplemental oxygen at a flow rate of 4 L/min or higher within the first 30 minutes after PACU admission. The predictive performance of the ROX index will be assessed using receiver operating characteristic (ROC) analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective septorhinoplasty or endoscopic sinus surgery under general anesthesia will be included in this study. All participants will undergo standard preoperative assessment, including measurement of oxygen saturation and respiratory rate on room air, and will be monitored postoperatively in the post-anesthesia care unit (PACU) according to routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Scheduled for elective septorhinoplasty or endoscopic sinus surgery\n* Undergoing surgery under general anesthesia\n* Ability to undergo preoperative measurement of oxygen saturation and respiratory rate on room air\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>65 years\n* ASA physical status III or higher\n* Known severe cardiopulmonary disease (e.g., advanced chronic obstructive pulmonary disease, pulmonary hypertension, severe heart failure)\n* Active respiratory tract infection in the preoperative period\n* Body mass index (BMI) \\>35 kg/m²\n* Requirement for long-term supplemental oxygen therapy\n* Refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07344103', 'briefTitle': 'Preoperative ROX Index for Predicting Early Postoperative Hypoxemia in ENT Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Association of the Preoperative ROX Index With Early Postoperative Hypoxemia in Adult Patients Undergoing Elective Septorhinoplasty and Endoscopic Sinus Surgery: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '324-2025'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rox ındex', 'type': 'DIAGNOSTIC_TEST', 'description': 'No intervention; observational study only.'}]}, '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'}}}}