[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623641":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":10,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":78,"overallStatus":85,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Bursa Sevket Yilmaz Training and Research Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Major Surgery",null,"Adult patients aged 18 years and older undergoing major surgical procedures under general anesthesia will be included in this cohort. Major surgery is defined as surgical procedures associated with a risk of significant blood loss and\u002For impaired tissue perfusion, requiring invasive arterial blood pressure monitoring and hourly arterial blood gas analysis. Eligible procedures include major abdominal, neurosurgical, and major orthopedic surgeries.\n\nAll anesthetic and surgical management will be performed according to standard clinical practice. The study does not involve any experimental intervention or alteration of routine clinical care. Submental tissue oxygenation and microvascular reactivity will be monitored intraoperatively using non-invasive near-infrared spectroscopy techniques as part of observational data collection.",[13],"Other: No intervention. This is a prospective observational study. Near-infrared spectroscopy measurements are performed for monitoring purposes only and do not influence clinical management.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","No intervention. This is a prospective observational study. Near-infrared spectroscopy measurements are performed for monitoring purposes only and do not influence clinical management.","This study does not include any therapeutic, diagnostic, or experimental intervention. It is a prospective observational study in which non-invasive near-infrared spectroscopy is used solely for intraoperative monitoring of submental tissue oxygenation and microvascular reactivity. Study measurements are collected for research purposes only and do not guide or alter anesthetic, surgical, or transfusion-related clinical decisions. All perioperative management is conducted according to standard institutional practice by the responsible clinical team.",[9],[21],{"name":22,"affiliation":23,"role":24},"Korgün Ökmen","Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences, Bursa","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+90 505 708 10 21","korgunokmen@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Gürcan Güler","+90 541 975 04 07","gurcanguler.45@gmail.com",[35],{"facility":36,"status":10,"city":37,"state":10,"zip":10,"country":38,"countryCode":10,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital","Bursa","Turkey (Türkiye)",{"type":40,"coordinates":41},"Point",[42,43],29.06013,40.19559,{"lat":43,"lon":42},[46,48,50,51],{"name":47,"role":27,"phone":28,"phoneExt":10,"email":29},"Principal Investigator",{"name":49,"role":27,"phone":32,"phoneExt":10,"email":33},"Investigator",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"name":31,"role":52,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"type":24,"investigatorFullName":31,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Consultant Anesthesiologist and Intensivist","100623641","submental-tissue-oxygenation-and-arterial-lactate-in-major-surgery-100623641",false,"NCT07399275","Submental Tissue Oxygenation and Arterial Lactate in Major Surgery","Relationship Between Submental Tissue Oxygenation, Microvascular Reactivity, and Arterial Lactate During Major Surgical Procedures","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Scheduled for major surgical procedures under general anesthesia\n* Major surgery defined as procedures associated with a risk of significant blood loss and\u002For impaired tissue perfusion, requiring invasive arterial blood pressure monitoring and hourly arterial blood gas analysis\n* Planned intraoperative arterial catheter placement as part of routine clinical care\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Refusal or inability to provide informed consent\n* Absence of invasive arterial blood pressure monitoring\n* Known pregnancy\n* Severe peripheral vascular disease affecting upper extremities\n* Anatomical abnormalities or skin conditions preventing placement of NIRS sensors on the submental or thenar regions\n* Emergency surgery requiring immediate intervention\n* Preoperative severe metabolic acidosis (arterial pH \\\u003C 7.20)",true,"ALL","18 Years",{"count":66,"type":67},150,"ESTIMATED","OBSERVATIONAL","During major surgical procedures performed under general anesthesia, changes in blood flow and oxygen delivery to tissues may occur due to blood loss, hemodynamic fluctuations, and anesthesia-related physiological effects. These changes can lead to impaired tissue perfusion, which is commonly reflected by increased arterial lactate levels. However, lactate measurements are intermittent and may not detect early perfusion abnormalities.\n\nThis prospective observational study aims to investigate the relationship between submental tissue oxygenation measured by near-infrared spectroscopy (NIRS), microvascular reactivity assessed by the vascular occlusion test, and arterial lactate levels during major surgery. Adult patients undergoing major abdominal, neurosurgical, or orthopedic procedures will be monitored intraoperatively using non-invasive NIRS techniques, while arterial blood gas analyses will be performed as part of routine clinical care.\n\nThe study does not involve any changes to standard anesthesia or surgical management. All treatments and clinical decisions will be made by the responsible care team according to routine practice. By evaluating non-invasive indicators of tissue oxygenation and microvascular function, this study aims to improve the understanding of early intraoperative tissue perfusion changes and their association with metabolic markers.",[71,72,73,74,75,76,77,9],"Microcirculatory Dysfunction","Tissue Hypoperfusion","Microcirculatory Status","Microvascular Circulation","Near Infrared Spectroscopy","Vascular Occlusion Test","Lactate Blood Increase",[79,80,81,82,83,84],"tissue hypoperfusion","microvascular circulation","Near infrared spectroscopy","vascular occlusion","lactate blood increase","Major surgery","NOT_YET_RECRUITING","2026-02-03",{"date":88,"type":89},"2026-02-10","ACTUAL",{"date":91,"type":67},"2026-02-15",{"date":93,"type":67},"2027-02-15",{"name":5,"class":6},1]