An interventional study of Standard High $FiO_2$ Strategy and Guided Low $FiO_2$ Strategy in Thoracic Surgery and Anesthesia, sponsored by Dicle University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Dicle University · Not applicable, Interventional, and Diagnostic
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.
Dicle University is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Renal failure. Neuromuscular disease. Pregnancy. Expected OLV duration less than 30 minutes (\< 30 min)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing elective thoracic surgery managed with a cerebral oximetry-guided low FiO\_2 ventilation strategy
Procedure: Guided Low $FiO_2$ Strategy
Patients undergoing elective thoracic surgery managed with a standard conventional ventilation strategy
Procedure: Standard High $FiO_2$ Strategy
Patients receive the standard institutional anesthesia protocol where $SpO\_2$ values are strictly maintained above 90%
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
Incidence of Postoperative Delirium
Assessed using the 3D-CAM (Confusion Assessment Method) test
Time frame: Postoperative days 1 to 3 (up to hospital discharge)
Incidence of Cerebral Desaturation
Cerebral desaturation monitored via near-infrared spectroscopy (rSO₂, %)
Time frame: Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)
Incidence of Hypoxemia
Incidence of hypoxemia defined as SpO₂ \< 90% during one-lung ventilation (%)
Time frame: During one-lung ventilation (OLV), approximately up to 2 hours
Mean Fraction of Inspired Oxygen (FiO₂)
Mean FiO₂ levels required to maintain adequate oxygenation during one-lung ventilation
Time frame: During one-lung ventilation (OLV), approximately up to 2 hours
Mean Arterial Pressure (MAP)
Intraoperative mean arterial pressure changes monitored via standard non-invasive or invasive blood pressure measurement (mmHg)
Time frame: Intraoperative period, approximately up to 4 hours
Heart Rate (HR)
Intraoperative heart rate changes monitored via standard ECG (beats per minute)
Time frame: Intraoperative period, approximately up to 4 hours
Plan to share: Yes
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Start is estimated for Jun 2026; primary completion for Aug 2026, 1 month later.
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