Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard High $FiO_2$ Strategy, Guided Low $FiO_2$ Strategy.
- Who it may be relevant to
- Registry conditions: Thoracic Surgery, Anesthesia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery
Overview
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.
Interventions
- Procedure Standard High $FiO_2$ Strategy
Patients receive the standard institutional anesthesia protocol where $SpO\_2$ values are strictly maintained above 90% - Procedure Guided Low $FiO_2$ Strategy
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
Primary outcome measures
- Incidence of Postoperative Delirium [Time frame: Postoperative days 1 to 3 (up to hospital discharge)]
- Incidence of Cerebral Desaturation [Time frame: Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)]
Secondary outcome measures (4)
- Incidence of Hypoxemia [Time frame: During one-lung ventilation (OLV), approximately up to 2 hours]
- Mean Fraction of Inspired Oxygen (FiO₂) [Time frame: During one-lung ventilation (OLV), approximately up to 2 hours]
- Mean Arterial Pressure (MAP) [Time frame: Intraoperative period, approximately up to 4 hours]
- Heart Rate (HR) [Time frame: Intraoperative period, approximately up to 4 hours]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Turkey (Türkiye) · 1 center
- Dicle University — Diyarbakır
Identifiers
NCT: NCT07659483 · 74/2026