Submental Tissue Oxygenation and Arterial Lactate in Major Surgery
Relationship Between Submental Tissue Oxygenation, Microvascular Reactivity, and Arterial Lactate During Major Surgical Procedures
1 other identifier
observational
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedStudy Start
First participant enrolled
February 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
February 10, 2026
February 1, 2026
1 year
February 3, 2026
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between submental tissue oxygenation and arterial lactate levels
The strength and direction of the association between intraoperative submental tissue oxygenation measured by near-infrared spectroscopy and arterial lactate levels during major surgery.
Intraoperatively, from anesthesia induction to the end of surgery
Secondary Outcomes (3)
Correlation between microvascular reactivity and arterial lactate levels
Intraoperatively, from anesthesia induction to the end of surgery
Intraoperative submental NIRS desaturation events
Intraoperatively, from anesthesia induction to the end of surgery
Relationship between submental tissue oxygenation and microvascular reactivity
Intraoperatively, from anesthesia induction to the end of surgery
Study Arms (1)
Major Surgery
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/or 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. All 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.
Interventions
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.
Eligibility Criteria
The study population consists of adult patients aged 18 years and older undergoing major surgical procedures under general anesthesia at a single tertiary care center. Major surgery includes abdominal, neurosurgical, and major orthopedic 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 as part of routine clinical care. All participants are enrolled prospectively and monitored intraoperatively without any alteration to standard anesthetic or surgical management.
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
Related Publications (3)
Bakker J, Nijsten MW, Jansen TC. Clinical use of lactate monitoring in critically ill patients. Ann Intensive Care. 2013 May 10;3(1):12. doi: 10.1186/2110-5820-3-12.
PMID: 23663301BACKGROUNDGomez H, Mesquida J, Simon P, Kim HK, Puyana JC, Ince C, Pinsky MR. Characterization of tissue oxygen saturation and the vascular occlusion test: influence of measurement sites, probe sizes and deflation thresholds. Crit Care. 2009;13 Suppl 5(Suppl 5):S3. doi: 10.1186/cc8001. Epub 2009 Nov 30.
PMID: 19951387RESULTScheeren TW, Schober P, Schwarte LA. Monitoring tissue oxygenation by near infrared spectroscopy (NIRS): background and current applications. J Clin Monit Comput. 2012 Aug;26(4):279-87. doi: 10.1007/s10877-012-9348-y. Epub 2012 Mar 31.
PMID: 22467064RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Korgün Ökmen
Department of Anesthesiology and Reanimation, Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences, Bursa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Anesthesiologist and Intensivist
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 10, 2026
Study Start
February 15, 2026
Primary Completion (Estimated)
February 15, 2027
Study Completion (Estimated)
February 15, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share