Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery.

NCT07659483 | Not Yet Recruiting

• 1 other identifier: 74/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary (Kısa Özet)The purpose of this study is to evaluate the safety and efficacy of a cerebral oximetry-guided low fraction of inspired oxygen (FiO\_2) ventilation strategy compared to a standard high FiO\_2 strategy in patients undergoing elective thoracic surgery requiring one-lung ventilation (OLV).Oxygen toxicity and related postoperative pulmonary complications remain significant risks during thoracic anesthesia. While standard protocols often rely on high inspired oxygen concentrations to maintain peripheral oxygen saturation (SpO\_2), this approach may induce hyperoxia. Conversely, lowering FiO\_2 arbitrarily can increase the risk of hypoxemia or compromise tissue oxygenation. This prospective, parallel-group, 1:1 randomized, single-blind clinical trial aims to safely reduce intraoperative oxygen exposure by using regional cerebral oxygen saturation (rSO\_2) monitoring as a physiological guide.A total of 60 participants aged 18 and older, classified as ASA I-III and scheduled for elective thoracic surgery, will be randomly assigned to one of two arms:Experimental Group (Guided Low FiO\_2 Strategy): Ventilation will be initiated at a low FiO\_2 of 0.5. The FiO\_2 level will not be increased unless peripheral saturation (SpO\_2) falls below 90% or cerebral oxygenation (rSO\_2) drops below 80% of the patient's baseline value.Active Comparator Group (Standard Strategy): Patients will receive conventional anesthesia management, maintaining standard high FiO\_2 levels to keep SpO\_2 above 90% without cerebral oximetry guidance.The primary outcomes to be measured are the incidence of cerebral desaturation during the perioperative period and the incidence of postoperative delirium assessed via the 3D-CAM tool until hospital discharge. Secondary outcomes include intraoperative hemodynamic stability, arterial blood gas parameters (PaO\_2, PaCO\_2, pH, lactate), incidence of hypoxemia, total one-lung ventilation duration, postoperative cognitive dysfunction (POCD), and lengths of stay in both the intensive care unit (ICU) and the hospital.By utilizing real-time non-invasive cerebral oximetry, the study intends to demonstrate a safe ventilation protocol that minimizes oxygen toxicity without compromising cerebral oxygenation or clinical recovery outcomes.

Conditions

Thoracic Surgery; Anesthesia

Outcome Measures

Primary Outcomes (2)

• Incidence of Postoperative Delirium

  Assessed using the 3D-CAM (Confusion Assessment Method) test

  Postoperative days 1 to 3 (up to hospital discharge)

• Incidence of Cerebral Desaturation

  Cerebral desaturation monitored via near-infrared spectroscopy (rSO₂, %)

  Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)

Secondary Outcomes (4)

• Incidence of Hypoxemia

  During one-lung ventilation (OLV), approximately up to 2 hours

• Mean Fraction of Inspired Oxygen (FiO₂)

  During one-lung ventilation (OLV), approximately up to 2 hours

• Mean Arterial Pressure (MAP)

  Intraoperative period, approximately up to 4 hours

• Heart Rate (HR)

  Intraoperative period, approximately up to 4 hours

Study Arms (2)

Low FiO2 Group

EXPERIMENTAL

Patients undergoing elective thoracic surgery managed with a cerebral oximetry-guided low FiO\_2 ventilation strategy

Procedure: Guided Low $FiO_2$ Strategy

Standard Group

ACTIVE COMPARATOR

Patients undergoing elective thoracic surgery managed with a standard conventional ventilation strategy

Procedure: Standard High $FiO_2$ Strategy

Interventions

Standard High $FiO_2$ Strategy PROCEDURE

Patients receive the standard institutional anesthesia protocol where $SpO\_2$ values are strictly maintained above 90%

Standard Group

Guided Low $FiO_2$ Strategy PROCEDURE

Following general anesthesia induction, the initial $FiO\_2$ will be set to 0.5. $FiO\_2$ will not be increased unless the patient's pulse oximetry ($SpO\_2$) drops below 90% or regional cerebral oxygen saturation ($rSO\_2$) drops below 80% of its baseline value

Low FiO2 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older. Scheduled for elective thoracic surgery requiring one-lung ventilation (OLV). American Society of Anesthesiologists (ASA) Physical Status classification I-III.

You may not qualify if:

• History of cerebrovascular disease. Left ventricular ejection fraction Pulmonary hypertension. Interstitial lung disease.
• Renal failure. Neuromuscular disease. Pregnancy. Expected OLV duration less than 30 minutes (\< 30 min)

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle University

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

Location

Central Study Contacts

Ayhan Kaydu, associate professor

CONTACT

+90 505 556 7939; akaydu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)