Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery.

Официальное название

Safety and Efficacy of Cerebral Oximetry-Guided Low FiO2 Strategies in Thoracic Surgery

Обзор

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.

Вмешательства

• Процедура Standard High $FiO_2$ Strategy
  Patients receive the standard institutional anesthesia protocol where $SpO\_2$ values are strictly maintained above 90%
• Процедура 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

Первичные конечные точки

• Incidence of Postoperative Delirium [Срок оценки: Postoperative days 1 to 3 (up to hospital discharge)]
• Incidence of Cerebral Desaturation [Срок оценки: Perioperative period (from anesthesia induction to end of surgery, approximately up to 4 hours)]

Вторичные конечные точки (4)

• Incidence of Hypoxemia [Срок оценки: During one-lung ventilation (OLV), approximately up to 2 hours]
• Mean Fraction of Inspired Oxygen (FiO₂) [Срок оценки: During one-lung ventilation (OLV), approximately up to 2 hours]
• Mean Arterial Pressure (MAP) [Срок оценки: Intraoperative period, approximately up to 4 hours]
• Heart Rate (HR) [Срок оценки: Intraoperative period, approximately up to 4 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Turkey (Türkiye) · 1 центр

• Dicle University — Diyarbakır

Идентификаторы

NCT: NCT07659483 · 74/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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