Submental Tissue Oxygenation and Arterial Lactate in Major Surgery

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Conditions studied: Microcirculatory Dysfunction, Tissue Hypoperfusion, Microcirculatory Status, Microvascular Circulation, Near Infrared Spectroscopy, Vascular Occlusion Test, Lactate Blood Increase, Major Surgery

In brief

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. This 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. The 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.

Key facts

Study ID

NCT07399275

Run by

Bursa Sevket Yilmaz Training and Research Hospital

People needed

150

Starts

2026-02-15

Expected to finish

2027-02-15

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults aged 18 years and older
• Scheduled for major surgical procedures under general anesthesia
• Major surgery defined as procedures associated with a risk of significant blood loss and/or impaired tissue perfusion, requiring invasive arterial blood pressure monitoring and hourly arterial blood gas analysis
• Planned intraoperative arterial catheter placement as part of routine clinical care
• Ability to provide written informed consent

You may not qualify if…

• Age younger than 18 years
• Refusal or inability to provide informed consent
• Absence of invasive arterial blood pressure monitoring
• Known pregnancy
• Severe peripheral vascular disease affecting upper extremities
• Anatomical abnormalities or skin conditions preventing placement of NIRS sensors on the submental or thenar regions
• Emergency surgery requiring immediate intervention
• Preoperative severe metabolic acidosis (arterial pH < 7.20)

Where it is running

• University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital — Bursa, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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