The Effect of Apneic Oxygenation of the Non-ventilated Lung on the Expression of Hypoxia-inducible Factor-1 Alpha (HIF-1α) and Interleukin-6 (IL-6) in Lung Tissue During Lung Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Expression of HIF -1α in lung tissue
研究概览
简要总结
This study investigates the effect of apneic oxygenation of the non-ventilated lung on local and systemic inflammatory response during lung cancer surgery.
Patients undergoing surgical resection of lung cancer often require one-lung ventilation during anaesthesia. This results in alveolar hypoxia accompanied by upregulated expression of inflammatory markers. Apneic oxygenation of the non-ventiladed lung may influence inflammatory processes and oxygenation during surgery. The aim of this study is to evaluate whether apneic oxygenation affects inflammatory markers in lung tissue and postoperative recovery in patients undergoing lung cancer surgery. The study is conducted at a single center and includes adult patients scheduled for elective lung cancer surgery. Data will be collected durig the perioperative period. The results of this study may contribute to improved anaesthetic management and patient outcomes during thoracic surgery.
详细描述
PARTICIPANTS:
This study will include 56 patients undergoing surgical lung resection for lung cancer. The patients will be divided into two groups: patients who will receive apneic oxygenation of the non-ventilated lung during surgery and patients who will not receive apneic oxygenation during lung resection for lung cancer.
MATERIALS AND METHODS
Preoperative Preparation and Randomization
All patients will undergo a preoperative evaluation prior to surgery, during which perioperative risk will be assessed based on existing comorbidities in accordance with the standardized protocol of the American Society of Anesthesiologists (ASA). Before surgery, and after providing written informed consent, baseline demographic data will be recorded, including age, sex, body weight, height, and body mass index (BMI). The presence of comorbidities and details of chronic medications will also be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Patients scheduled to undergo surgical resection of a single lung segment for lung cancer
- •Written informed consent provided
排除标准
- •Age younger than 18 years
- •Chronic corticosteroid therapy and/or other immunomodulatory treatments
- •Severe pulmonary diseases, including:
- •Chronic obstructive pulmonary disease classified as GOLD stage 3-4 (Global Initiative for Chronic Obstructive Lung Disease).
- •Severe asthma according to GINA classification (Global Initiative for Asthma), step
- •Severe interstitial lung disease defined by: Forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted, presence of extensive pulmonary fibrosis on computed tomography (CT)
- •Surgical procedure expected to last less than 2 hours
- •Intraoperative hemodynamic instability, defined as: Mean arterial pressure < 60 mmHg for more than 30 minutes despite adequate volume resuscitation, requirement for high-dose vasopressor support (norepinephrine > 0.2 µg/kg/min)
- •New-onset intraoperative cardiac arrhythmias
- •Significant intraoperative blood loss, defined as the need for transfusion of more than two units of packed red blood cells
- •Intraoperative ventilatory instability, defined as: Severe hypoxemia (PaO₂ < 60 mmHg or SpO₂ < 85% with FiO₂ 1.0), hypercapnia (PaCO₂ > 70 mmHg with pH < 7.2), inability to achieve adequate ventilation.
研究组 & 干预措施
Apneic Oxygenation
Patients receive apneic oxygenation of non-ventilated lung during lung cancer surgery.
干预措施: Apnoeic Oxygenation (Procedure)
Control Group
Patients receive standard ventilation during lung cancer surgery.
干预措施: Standard Ventilation (Procedure)
结局指标
主要结局
Expression of HIF -1α in lung tissue
时间窗: Intraoperative (during lung cancer surgery)
Expression of hypoxia inducible factor 1 alpha (HIF 1α ) in lung tissue will be assessed to evaluate tissue hypoxia in patients receiving apneic oxygenation of the non-ventilated lung compared with those receiving standard ventilation during lung cancer surgery.
Expression of IL-6 in lung tissue
时间窗: Intraoperative (during lung cancer surgery)
Expression of interleukin 6 (IL-6) in lung tissue will be assessed to evaluate the local inflammatory response in patients receiving apneic oxygenation of the non-ventilated lung compared with those receiving standard ventilation during lung cancer surgery.
次要结局
- Changes in leukocyte count(From preoperative baseline to 24 hours after surgery.)
- Changes in neutrophile count(From preoperative baseline to 24 hours after surgery.)
- Changes in arterial oxygen partial pressure (PaO2)(From preoperative baseline to 24 hours after surgery.)
- Changes in arterial carbon dioxide partial pressure (PaCO2)(From preoperative baseline to 24 hours after surgery.)
- Incidence of postoperative complications(Perioperative)