Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT06404151
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients', 'timeFrame': 'after intubation time until spO2 reaches to 97% and 94% and ori reaches to the plato.Expected to take approximately five minutes', 'description': 'The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients (BMI 30-40 kg/m\\^2) (weight and height will be combined to report BMI in kg/m\\^2)'}], 'secondaryOutcomes': [{'measure': 'Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients', 'timeFrame': 'time until spo2 is 94% and 97% and ori reaches to the plato.Expected to take approximately five minutes', 'description': 'Our secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.'}]}, 'conditionsModule': {'keywords': ['Oxygen reserve index,', 'Preoxygenation', 'Cerebral Oxygen Saturation'], 'conditions': ['Oxygen Deficiency']}, 'referencesModule': {'references': [{'pmid': '28791567', 'type': 'RESULT', 'citation': 'Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.'}, {'pmid': '32815872', 'type': 'RESULT', 'citation': 'Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients who are sensitive to hypoxia. Our secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.', 'detailedDescription': 'Standard noninvasive monitoring will be applied to the patients taken to the operating table, and heart rate, mean arterial pressure, peripheral oxygen saturation (SpO2), oxygen reserve index (ORI), regional cerebral oxygen saturation, etCO2 values will be recorded. Cerebral oximeter probe placed in the middle of the forehead (every second Cerebral oxygen saturation will be continuously monitored using a rcSO2 reading) (Massimo)Preoxygenation will be performed until the expiratory O2 concentration is 90% (during spontaneous ventilation, FIO2 will be kept between 100% 6 lt7min flow rate and EtCO2 30-35 mmHg). 2 mg midazolam, 2 ug General anesthesia with /kg fentanyl, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 100% O2 will be applied and intubated with a videolaryngoscope. The breathing circuit will be disconnected from the endotracheal tube until the SpO2 drops to 94%. At that time, the breathing circuit will be connected and the patients will be ventilated with 100% FiO2, 8 ml kg-1 ideal body weight, targeted tidal volume, and 5 cm H2O positive end-expiratory pressure until the ORI plateaus. Throughout this process, ORI and cerebral oxygen saturation will be recorded continuously. ORI and rcO2 data will be compared at seven specific time points ( (1) during the basal period; (2) at the end of preoxygenation when ORI reaches a plateau; (3) at the beginning of intubation; (4) when SpO2 reaches 97%; (5) when SpO2 reaches 94% (6) ORI reaches a plateau again (during ventilation with 100% FiO2), and (7) SpO2 reaches baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 patients with ASA I-III, of both genders, between 18-75 years of age, with a BMI of 40\\>30 kg m2 and intubated under general anesthesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients\n* The ages of 18-75\n* Obese BMI (40\\>BMI\\>30 kgm\\^2)\n* Undergoing intubated elective surgery\n\nExclusion Criteria:\n\n* Patients with significant cardiopulmonary comorbidities\n* BMI\\>40 kgm\\^2 and BMI\\<30 kg m\\^2\n* ASA\\>3\n* Patients under 18 years and over 75 years of age'}, 'identificationModule': {'nctId': 'NCT06404151', 'briefTitle': 'Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation in Determining Hypoxia in Obese Patients', 'orgStudyIdInfo': {'id': '2023/514/246/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese Patients', 'description': '60 patients with ASA I-III, of both genders, between 18-75 years of age, with a BMI of 40\\>30 kg m2 and intubated under general anesthesia', 'interventionNames': ['Device: monitoring']}], 'interventions': [{'name': 'monitoring', 'type': 'DEVICE', 'description': 'rc02, ORI , spO2', 'armGroupLabels': ['Obese Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gülten Arslan, Dr', 'role': 'CONTACT', 'email': 'gulten.arslan@yahoo.com.tr', 'phone': '05323620366'}, {'name': 'Banu Eler Cevik, Prof', 'role': 'CONTACT', 'email': 'banueler@yahoo.com', 'phone': '5323969539'}], 'facility': 'University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Gülten A Arslan, Assos Prof', 'role': 'CONTACT', 'email': 'gulten.arslan@yahoo.com.tr', 'phone': '05325620366'}, {'name': 'Banu Eler Cevik, Prof', 'role': 'CONTACT', 'email': 'banueler@yahoo.com', 'phone': '5323969536'}], 'overallOfficials': [{'name': 'Gülten A Arslan, Assos Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr Lütfi Kırdar City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I will share the parameters and results of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assos prof', 'investigatorFullName': 'Gülten Arslan', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}