Effects of Permissive Hypercapnia During Lung Surgery on Inflammatory Biomarkers in Serum and Bronchoalveolar Lavage Fluid: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Effect of permissive hypercapnia on the inflammatory response during one-lung ventilation
研究概览
简要总结
The primary objective was to evaluate the effects of permissive hypercapnia on inflammatory biomarkers in bronchoalveolar lavage fluid and serum during one-lung ventilation. The secondary objective was to assess the influence of different ventilation modes on these inflammatory responses.
Methods: Forty patients undergoing elective lung surgery requiring OLV were prospectively enrolled an allocated to either a normocapnic (n=20) or hypercapnic group group (n=20). BAL concentrations of TNF-α, IL-1β, IL-6, and IL-8 were measured before and after intervention. Serum IL-6, C-reactive protein (CRP), and leukocyte counts were also assessed. Patients were further stratified according to ventilation mode (PC or VC).
Outcome measures: Primary outcome: change of bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α , IL-1β, IL-6, and IL-8) as well as in serum (IL-6, CRP, and WBC) between the normocapnic and hypercapnic groups during one-lung ventilation. Secondary outcome: whether the inflammatory response differed according to the ventilation mode (pressure-controlled versus volume-controlled ventilation).
详细描述
Following admission to the preoperative area, demographic and clinical data were recorded, including age, sex, height, body weight, ideal body weight (IBW), comorbidities, smoking status, and ASA physical status classification. An arterial catheter was inserted before induction of anesthesia to allow continuous invasive blood pressure monitoring and arterial blood gas analysis.
Patients were pre-oxygenated with 100% oxygen for 3-5 minutes before induction of anesthesia. General anesthesia was induced and maintained using target-controlled infusion (TCI) of propofol with target effect-site concentration (Ceff) of 2.0-6.0 ng/ml (Schnider model) and remifentanil with a target-effect site concentration (Ceff) of 2.0-8.0 ng/ml (Minto model). Neuromuscular blockade was achieved with rocuronium bromide (0.6 mg/kg). The depth of anesthesia was monitored using the Bispectral Index (BIS) and were maintained between 40 and 60.
Following induction, all patients were intubated with a double-lumen endotracheal tube (Rüsch, Bronchopart, Teleflex, USA). Correct placement of the tube was confirmed by fiberoptic bronchoscopy immediately after intubation and reassessed following lateral positioning.
During two-lung ventilation, patients in the VC group received a tidal volume of 7 mL/kg IBW. During OLV, tidal volume was reduced to 5 mL/kg IBW. For patients ven-tilated using the PC mode, inspiratory pressure was adjusted to achieve equivalent tidal volumes. PEEP was initially set at 5 cm H₂O and remained unchanged unless hypoxemia occurred. The fraction of inspired oxygen (FiO₂) was initially set at 1.0 and reduced to 0.5 after initiation of OLV. The intended strategy was to minimize FiO2 at 0.5; however, FiO2 was increased when significant hypoxemia persisted for several minutes. Prior to and following the initiation of OLV, an alveolar recruitment maneuver was applied (manual inflations for 10-40 seconds to achieve a peak airway pressure of 30-40 cmH20). In cases of severe hypoxemia (<88%), the first intervention was an increase in the inspired oxygen fraction (FiO₂). If adequate oxygenation was not achieved, further ventilatory adjustments were implemented, including increases in PEEP, and inspiratory time, as well as application of the recruitment maneuver according to the clinical situation and ventilatory parameters.
Respiratory rate was adjusted to maintain the predefined PaCO₂ targets:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants were aged 18-85 years,
- •classified as American Society of Anesthesiologists (ASA) physical status I-III, --scheduled for procedures expected to last at least 60 minutes, with anticipated OLV for the the majority of the intraoperative period.
排除标准
- •body mass index (BMI) > 35 kg/m2;
- •impaired pulmonary function (vital capacity of forced expiratory volume in 1 second (FEV1) < 50% of predicted values);
- •chronic infection;
- •intracranial hypertension;
- •prior intracranial hemorrhage;
- •presence of active extrapulmonary malignancy;
- •chronic pulmonary diseases (including chronic pneumonia, pneumoconiosis and silicosis);
- •pulmonary hypertension;
- •severe chronic obstructive pulmonary disease (COPD) with chronic hypercapnia;
- •patients undergoing bilobectomy or pneumonectomy
研究组 & 干预措施
Permissive hypercapnia group
The permissive hypercapnia during one-lung ventilation was used. The target CO2 values were 55-75momHg. Then the patients were divided into volume-controlled mode of ventilation or pressure-controlled mode.
干预措施: Allowed permissive hypercapnia (Other)
Normocapnic group
Normocapnia during protective one-lung ventilation was used. And the patients were further divided in volume-controlled or pressure-controlled mode of ventilation
干预措施: Allowed permissive hypercapnia (Other)
结局指标
主要结局
Effect of permissive hypercapnia on the inflammatory response during one-lung ventilation
时间窗: After induction of anesthesia and at the end of surgery
The primary outcome of the study was to evaluate the effect of permissive hypercapnia on the inflammatory response during one-lung ventilation by comparing a prespecified panel of inflammatory biomarkers between the normocapnic and hypercapnic groups. The primary outcome measures included BAL concentrations of TNF-α , IL-1β, IL-6, and IL-8, together with serum IL-6, CRP, and WBC count, measured at predefined sampling time points.
次要结局
未报告次要终点
研究者
Milena Stojanovic
specialist in anesthesia, resuscitation and intensive care
University of Nis