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Submental Tissue Oxygenation and Arterial Lactate in Major Surgery

NCT07399275 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Microcirculatory Dysfunction
  • Tissue Hypoperfusion
  • Microcirculatory Status
  • Microvascular Circulation
  • Near Infrared Spectroscopy
  • Vascular Occlusion Test
  • Lactate Blood Increase
  • Major Surgery

Interventions

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.

Sponsors & Collaborators

  • Bursa Sevket Yilmaz Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Korgün Ökmen · Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences, Bursa

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2027-02-15
Completion
2027-02-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399275 on ClinicalTrials.gov