Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:53 AM
Study NCT ID:
NCT07326293
Status:
RECRUITING
Last Update Posted:
2026-01-08
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D000860', 'term': 'Hypoxia'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is the association between Oxygen Reserve Index (ORI) warning time and tolerable apnea time. ORI warning time is defined as the time interval from the onset of the ORI alarm triggered by a downward trend to the decrease of per', 'timeFrame': 'Peri-induction period at predefined time points baseline; after 3 minutes of preoxygenation; after 2 minutes of bag-mask ventilation following intubation; during apnea at SpO₂ 94%; and after 2 minutes of ventilation with 100% oxygen', 'description': 'The primary outcome measure is the association between Oxygen Reserve Index (ORI) warning time and tolerable apnea time.\n\nORI warning time is defined as the time interval from the onset of the ORI alarm triggered by a downward trend to the decrease of peripheral oxygen saturation (SpO₂) to 94%.\n\nTolerable apnea time is defined as the duration from the end of ventilation after tracheal intubation to the decrease of SpO₂ to 94%.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxygen reserve indec', 'geriatric', 'desaturation'], 'conditions': ['Desaturation', 'Apnea, Hypoxia', 'Oxygen Reserve Index']}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate the relationship between the Oxygen Reserve Index (ORI) and tolerable apnea time in geriatric patients undergoing elective oncologic surgery under general anesthesia.\n\nPatients aged 65 years and older will be monitored using standard anesthesia monitoring and Masimo Rainbow SET® Pulse CO-Oximetry during anesthesia induction and tracheal intubation.\n\nTolerable apnea time will be defined as the duration from the end of ventilation after intubation to a decrease in peripheral oxygen saturation (SpO₂) to 94%.\n\nThe primary objective is to assess the association between ORI warning time and tolerable apnea time. Secondary objectives include evaluating the association between ORI values, arterial blood gas parameters at predefined time points, and the Clinical Frailty Scale.', 'detailedDescription': 'This study is a prospective, observational study. Patients aged 65 years and older who are scheduled for elective oncologic surgery at Ankara Bilkent City Hospital will be included. In all patients, the Clinical Frailty Scale will be routinely assessed during the preoperative period.\n\nIn this study, tolerable apnea time will be defined as the time until peripheral oxygen saturation (SpO₂), measured by pulse oximetry, decreases to 94%. Although SpO₂ values of 90% and above have been accepted in the literature, the World Health Organization defines normal SpO₂ as 95% and above and considers values of 94% and below as an indication for treatment.\n\nThe Oxygen Reserve Index (ORI) ranges from 0 to 1, and the ORI alarm value triggered by the device due to a downward trend will be recorded. ORI is a dimensionless index ranging from 1 (high oxygen reserve) to 0 (no oxygen reserve), which is measured by optically detecting changes in venous oxygen saturation (SvO₂) after arterial oxygen saturation (SpO₂) reaches 100%. ORI is measured using a multi-wavelength pulse co-oximeter placed on a fingertip.\n\nIn addition to routine anesthesia monitoring, including electrocardiography, pulse oximetry, and hemodynamic monitoring, patients will also be monitored using Masimo Rainbow SET® Pulse CO-Oximetry. Due to the oncologic nature of the surgeries and the associated risk of bleeding, close hemodynamic monitoring is required; therefore, invasive arterial blood pressure monitoring will be established in all patients before anesthesia induction.\n\nAll patients will be preoxygenated with 100% oxygen for 3 minutes. After establishing intravenous access, anesthesia induction will be performed using intravenous propofol at a dose of 2 mg/kg and fentanyl at a dose of 1 µg/kg. Neuromuscular blockade will be achieved with rocuronium at a dose of 0.6 mg/kg.\n\nAll patients will be intubated by an experienced anesthesiologist using a videolaryngoscope. Oxygen Reserve Index (ORI) and peripheral oxygen saturation (SpO₂) values will be recorded, and arterial blood gas analyses will be performed at five predefined time points: baseline (initial values), after 3 minutes of preoxygenation, after 2 minutes of bag-mask ventilation following intubation, during apnea when SpO₂ decreases to 94% without ventilation, and after 2 minutes of ventilation with 100% oxygen.\n\nORI warning time will be defined as the interval from the onset of the ORI alarm to the decrease of SpO₂ to 94%. SpO₂ warning time will be defined as the duration of the decrease in SpO₂ from 97% to 94%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'It will be studied in patients over the age of 65.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria for the files/records/materials to be included in the study:\n\nRecords of patients aged 65 years and older, classified as ASA physical status I-III, who are scheduled for elective oncologic surgery.\n\nExclusion criteria for the files/records/materials to be included in the study:\n\nRecords of patients with advanced coronary artery disease; advanced heart failure and/or valvular heart disease; carotid artery stenosis; left ventricular ejection fraction below 30%; rapid atrial fibrillation; body mass index (BMI) greater than 35 kg/m²; anticipated difficult airway; advanced-stage malignancy; or dementia.'}, 'identificationModule': {'nctId': 'NCT07326293', 'briefTitle': 'The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Effectiveness of Oxygen Reserve Index in Early Detection of Desaturation in Geriatric Patients Scheduled for Oncological Surgery; a Prospective, Observational Study.', 'orgStudyIdInfo': {'id': 'E2-24-8204'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Çankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muhlis Kuru', 'role': 'CONTACT', 'email': 'muhlis_kuru@hotmail.com', 'phone': '+905312089322'}, {'name': 'Muhlis Kuru', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Muhlis Kuru', 'role': 'CONTACT', 'email': 'muhlis_kuru@hotmail.com', 'phone': '+905312089322'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}