A Comparative Evaluation of Mechanical Ventilation Strategies and Their Hemodynamic Effects During Laparoscopic Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cardiac Index (CI)
研究概览
简要总结
Purpose: To compare hemodynamic effects of two different modes of ventilation (volume-controlled and pressure-controlled volume guaranteed) in patients undergoing laparoscopic gynecology surgeries with exaggerated Trendelenburg position.
Methods: Thirty patients undergoing laparoscopic gynecology operations were ventilated using either volume-controlled (Group VC) or pressure-controlled volume guaranteed mode (Group PCVG) (n = 15 for both groups). Hemodynamic variables were measured using Pressure Recording Analytical Method by radial artery cannulation in addition to peak and mean airway pressures and expired tidal volume.
详细描述
Laparoscopic nephrectomy requires the creation of pneumoperitoneum and lateral positioning, both of which may significantly affect respiratory mechanics and cardiovascular function. Increased intra-abdominal pressure and elevated intrathoracic pressure during pneumoperitoneum may reduce venous return, alter ventricular loading conditions, and impair cardiac output. Therefore, intraoperative ventilatory strategy may play a critical role not only in pulmonary protection but also in maintaining hemodynamic stability.
Lung-protective ventilation (LPV), characterized by low tidal volume, moderate positive end-expiratory pressure (PEEP), and periodic recruitment maneuvers, has been shown to reduce ventilator-induced lung injury and postoperative pulmonary complications. However, its hemodynamic consequences during laparoscopic surgery under pneumoperitoneum remain controversial.
This prospective, randomized, controlled study was designed to compare the effects of lung-protective ventilation and standard ventilation strategies on advanced hemodynamic parameters in patients undergoing elective laparoscopic nephrectomy.
Thirty ASA I-III patients aged 18-70 years were randomized into two groups:
Group A (Lung-Protective Ventilation): Tidal volume 6 mL/kg, PEEP 5-8 cmH₂O, periodic recruitment maneuvers.
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
盲法说明
Due to the nature of the intervention, the anesthesiology team administering the ventilation strategy was aware of group allocation. Patients were under general anesthesia during the intervention. Advanced hemodynamic parameters were recorded objectively using the PRAM monitoring system. Therefore, the study was conducted as an open-label trial without masking.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years
- •ASA physical status I-III
- •Scheduled for elective laparoscopic nephrectomy
- •Ability to provide written informed consent
排除标准
- •Emergency surgery
- •Hemodynamic instability
- •Severe cardiac disease (including significant valvular disease or uncontrolled arrhythmia)
- •Endocrine disorders affecting hemodynamic status
- •Hemoglobin < 10 g/dL
- •Known coagulation disorders
- •Ongoing anticoagulant therapy
- •Severe peripheral arterial disease
- •History of cerebrovascular accident
- •Advanced hepatic failure
- •Advanced renal failure
- •Body mass index (BMI) > 35 kg/m²
- •Conversion from laparoscopic to open surgery
- •Inability to maintain arterial catheterization
- •Refusal to participate
研究组 & 干预措施
Lung Protective Ventilation
Patients in this group received lung-protective ventilation consisting of a tidal volume of 6 mL/kg predicted body weight, positive end-expiratory pressure (PEEP) of 5-8 cmH₂O, and periodic recruitment maneuvers performed every 30 minutes during surgery.
干预措施: Lung Protective Ventilation (Procedure)
Standard Ventilation
Patients in this group received conventional mechanical ventilation with a tidal volume of 8-10 mL/kg predicted body weight and low PEEP (0-2 cmH₂O) without routine recruitment maneuvers.
干预措施: Lung Protective Ventilation (Procedure)
结局指标
主要结局
Cardiac Index (CI)
时间窗: Measured after induction of anesthesia, 10 minutes after pneumoperitoneum, 1 hour after pneumoperitoneum, after desufflation, and after extubation.
Change in Cardiac Index
次要结局
未报告次要终点
研究者
Elzem SEN
Assoc. Prof.
University of Gaziantep