The Effect of Different PEEP Levels Accompanied by PCV-VG Mode on Respiratory Mechanics and Gas Exchange in Lumbar Surgeries Performed in the Prone Position Under TIVA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Driving Pressure (ΔP)
研究概览
简要总结
This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.
详细描述
Prone positioning during lumbar spine surgery is associated with increased intrathoracic pressure, reduced lung compliance, and impaired ventilation-perfusion matching, which may negatively affect respiratory mechanics and gas exchange. Mechanical ventilation strategies, particularly the application of positive end-expiratory pressure (PEEP), play a critical role in preventing atelectasis and optimizing oxygenation.
Pressure-controlled ventilation with volume guarantee (PCV-VG) is a modern ventilation mode that ensures target tidal volume delivery while minimizing airway pressures, thereby reducing the risk of ventilator-induced lung injury. In recent years, driving pressure (ΔP) and mechanical power have emerged as important parameters reflecting lung stress and injury during mechanical ventilation.
This prospective randomized controlled trial aims to evaluate the effects of two different PEEP levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics and gas exchange in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Patients will be randomly assigned into two groups receiving either 5 cmH₂O or 8 cmH₂O PEEP. Ventilation will be standardized using PCV-VG mode with a tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.
Hemodynamic parameters and respiratory variables, including peak airway pressure, plateau pressure, dynamic compliance, airway resistance, tidal volume, and end-tidal CO₂, will be recorded at predefined time points. Arterial blood gas analyses will be performed at selected intervals to assess gas exchange.
The primary outcome of the study is driving pressure (ΔP), while secondary outcomes include mechanical power, oxygenation parameters, PaCO₂-EtCO₂ gradient, and physiologic dead space fraction (VD/VT).
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
This is an open-label study. Due to the nature of the intervention (ventilator settings), masking of care providers and investigators is not feasible.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 65 years
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective lumbar spine surgery in the prone position
- •Planned general anesthesia with total intravenous anesthesia (TIVA)
- •Ability to provide informed consent
排除标准
- •Body mass index (BMI) ≥ 30 kg/m²
- •History of significant pulmonary disease (e.g., COPD, asthma)
- •Severe cardiovascular disease
- •Pregnancy
- •Known difficult airway
- •Requirement for intraoperative vasopressor infusion due to hemodynamic instability
- •Conversion to different surgical position or change in surgical plan
- •Incomplete data or protocol deviation
研究组 & 干预措施
PEEP-8 Group
Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 8 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.
干预措施: Mechanical Ventilation (PEEP) (Device)
PEEP-5 Group
Participants in this group will receive mechanical ventilation with a positive end-expiratory pressure (PEEP) level of 5 cmH₂O during lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Ventilation will be performed using PCV-VG mode with a target tidal volume of 6-8 mL/kg predicted body weight and respiratory rate adjusted to maintain normocapnia.
干预措施: Mechanical Ventilation (PEEP) (Device)
结局指标
主要结局
Driving Pressure (ΔP)
时间窗: Intraoperative period (at predefined time points: T0, T2, T5)
Driving pressure (ΔP), calculated as the difference between plateau pressure (Pplat) and positive end-expiratory pressure (PEEP), will be used as the primary outcome to assess lung stress during mechanical ventilation.
次要结局
- Mechanical Power(Intraoperative period (T0, T2, T5))
- Oxygenation (PaO₂/FiO₂ Ratio)(Intraoperative period (T0, T2, T5))
- PaCO₂-EtCO₂ Gradient(Intraoperative period (T0, T2, T5))
- Physiological Dead Space Fraction (VD/VT)(Intraoperative period (T0, T2, T5))
- Dynamic Lung Compliance (Cdyn)(Intraoperative period (all time points))
- Peak Airway Pressure (Ppeak)(Intraoperative period (all time points))
研究者
Veli Fahri Pehlivan
Assistant Professor
Harran University