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临床试验/NCT07659483
NCT07659483尚未招募不适用

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

Dicle University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

Low FiO2 Group

Experimental

Patients undergoing elective thoracic surgery managed with a cerebral oximetry-guided low FiO_2 ventilation strategy

干预措施: Guided Low $FiO_2$ Strategy (Procedure)

Standard Group

Active Comparator

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

干预措施: Standard High $FiO_2$ Strategy (Procedure)

研究者

发起方
Dicle University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayhan Kaydu

Medicine Doctor Associate Professor in Anesthesiology

Dicle University

研究点 (1)

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