Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-28 @ 11:02 AM
Study NCT ID:
NCT07119866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Oxygen Reserve Index (ORi) in Apneic Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TIME FOR ORI TO FALL BELOW 0.24', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'TIME THE PATIENT STARTED TO WEAR A MASKS.'}], 'secondaryOutcomes': [{'measure': 'INITIAL ORI VALUE', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'ORI VALUE AT 2 MINUTES', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'AGE', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'American Society of Anesthesiologists (ASA) Score', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'SEX', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'BMI', 'timeFrame': 'WITHIN 10 MINUTES BEFORE INTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'PRESENCE OF A NASOGASTRIC TUBE', 'timeFrame': '10 MINUTES BEFORE EXTUBATION', 'description': 'Noted for each patient.'}, {'measure': 'Surgeon satisfaction', 'timeFrame': '10 MINUTES BEFORE EXTUBATION', 'description': 'Noted for each patient. Surgeon satisfaction according to ng usage status.'}, {'measure': 'PRESENCE OF LARYNGOSPASM', 'timeFrame': '10 MINUTES BEFORE EXTUBATION', 'description': 'Noted for each patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxygen Reserve Index', 'Apnea', 'Ventilation', 'Body Mass Index']}, 'descriptionModule': {'briefSummary': 'Background: The Oxygen Reserve Index (ORI) is a non-invasive parameter utilizing multi-wavelength pulse co-oximetry. ORI can provide early warnings of deteriorating oxygenation before changes are reflected in SpO₂ levels. This study aimed to investigate the feasibility of non-ventilated intubation in patients undergoing cholecystectomy as a means to achieve safe intubation without nasogastric tube placement, with reduced trauma and cost, and improved time efficiency.', 'detailedDescription': 'Obesity is a complex and chronic disease that significantly impacts respiratory physiology. It leads to increased work of breathing and reduced compliance of the chest wall. In morbidly obese individuals, there is a marked reduction in total lung capacity, vital capacity, forced expiratory volume in one second (FEV1), and forced vital capacity (FVC). Additionally, due to their elevated metabolic demands, these patients exhibit higher oxygen consumption rates.\n\nThe Oxygen Reserve Index (ORi) (Masimo Corp., Irvine, CA, USA) is an advanced, continuous, and non-invasive parameter that provides a relative indication of arterial partial pressure of oxygen (PaO₂).\n\nORI monitoring can be particularly beneficial in patients at risk for inadequate preoxygenation, those with difficult mask ventilation, hypoxemic patients with aspiration risk, rapid sequence induction scenarios, obese individuals, ICU intubations, and invasive ventilation cases. It has also been shown to provide early warnings of desaturation in select patient groups, contributing to improved patient safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients between the ages of 18-60 years, ASA 1-2, scheduled for elective laparoscopic cholecystectomy under general anesthesia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years\n* ASA 1-2\n* Mallampati score \\<2\n* Scheduled for elective laparoscopic cholecystectomy under general anesthesia\n\nExclusion Criteria:\n\n* \\<18 and \\>60 years\n* ASA 3-4\n* Initial ORI value below 0.24'}, 'identificationModule': {'nctId': 'NCT07119866', 'briefTitle': 'The Role of Oxygen Reserve Index (ORi) in Apneic Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Role of Oxygen Reserve Index (ORi) Monitoring in Optimizing Apneic Ventilation for Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'Oxygen Reserve Index'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ORI>0.24', 'description': 'Patients, aged between 18 and 60 years, classified as ASA physical status I-II,and with a Mallampati score \\<2, were enrolled.On the day of surgery, following identity verification and confirmation of the surgical site, patients were positioned on a warmed operating table.Standard monitoring was applied, including ECG, SBP and DBP, SpO₂, and the ORI.Preoxygenation was achieved by administering 100% oxygen via 8 deep breaths over 60 seconds.When the ORI value reached 0.4, intravenous anesthesia induction was initiated using propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6mg/kg.During muscle relaxation, patients were not ventilated via mask.The ORI value at the time of induction and at the 2nd minute post-induction was recorded.If the ORI dropped below 0.24 before the 2-minute mark, mask ventilation was initiated, and the time of intervention was noted.Endotracheal intubation was then performed using a standard,atraumatic technique after achieving adequate muscle relaxation.', 'interventionNames': ['Other: OXYGEN RESERVE INDEX']}, {'label': 'ORI<0.24', 'description': 'Patients, aged between 18 and 60 years, classified as ASA physical status I-II,and with a Mallampati score \\<2, were enrolled.On the day of surgery, following identity verification and confirmation of the surgical site, patients were positioned on a warmed operating table.Standard monitoring was applied, including ECG, SBP and DBP, SpO₂, and the ORI.Preoxygenation was achieved by administering 100% oxygen via 8 deep breaths over 60 seconds.When the ORI value reached 0.4, intravenous anesthesia induction was initiated using propofol 2 mg/kg, fentanyl 2 mcg/kg, and rocuronium 0.6mg/kg.During muscle relaxation, patients were not ventilated via mask.The ORI value at the time of induction and at the 2nd minute post-induction was recorded.If the ORI dropped below 0.24 before the 2-minute mark, mask ventilation was initiated, and the time of intervention was noted.Endotracheal intubation was then performed using a standard,atraumatic technique after achieving adequate muscle relaxation.', 'interventionNames': ['Other: OXYGEN RESERVE INDEX']}], 'interventions': [{'name': 'OXYGEN RESERVE INDEX', 'type': 'OTHER', 'description': 'Noted for each patient.', 'armGroupLabels': ['ORI<0.24', 'ORI>0.24']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ayşegül Özel Erdem', 'role': 'CONTACT', 'email': 'aysegulozell@gmail.com', 'phone': '05549777289'}, {'name': 'Ayça Özcan', 'role': 'CONTACT', 'email': 'draycaozcan@gmail.com', 'phone': '05057154125'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Ayça Özcan', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}