A Prospective Interventional Study Comparing Standard and Dynamic Compliance-Guided Individualized Positive End-Expiratory Pressure on Intraoperative Oxygenation and Postoperative Pulmonary Complications in Obese Patients Undergoing Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
研究概览
简要总结
This study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Obesity and prone positioning during spinal surgery are associated with reduced lung compliance, atelectasis, and an increased risk of postoperative pulmonary complications.
Participants will be allocated to receive either a fixed standard PEEP or an individualized PEEP level determined according to intraoperative dynamic lung compliance. Intraoperative oxygenation, respiratory mechanics, arterial blood gas parameters, and hemodynamic variables will be assessed at predefined time points. Postoperative pulmonary complications within the first 24 hours after surgery will also be evaluated.
The study seeks to determine whether individualized PEEP titration based on dynamic compliance offers physiological or clinical advantages compared with a standard PEEP strategy in this patient population.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-65 years
- •Body mass index (BMI) ≥30 kg/m²
- •Scheduled for elective spinal surgery under general anesthesia
- •Requirement for intraoperative mechanical ventilation
- •American Society of Anesthesiologists (ASA) physical status II-III
- •Provision of written informed consent
排除标准
- •Pre-existing severe pulmonary disease (e.g., COPD GOLD stage III-IV, restrictive lung disease)
- •Severe cardiac disease (e.g., heart failure with reduced ejection fraction, significant valvular disease)
- •History of thoracic surgery affecting lung mechanics
- •Pregnancy
- •Emergency surgery
- •Intraoperative need for deviation from the planned ventilation protocol
研究组 & 干预措施
Standard PEEP
Patients assigned to this arm receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the intraoperative period during mechanical ventilation.
干预措施: Standard PEEP (Device)
Dynamic Compliance-Guided Individualized PEEP
Patients assigned to this arm receive individualized positive end-expiratory pressure (PEEP) titrated according to intraoperative dynamic lung compliance, with the aim of optimizing respiratory mechanics while avoiding overdistension.
干预措施: Standard PEEP (Device)
结局指标
主要结局
Intraoperative Oxygenation (PaO₂/FiO₂ Ratio)
时间窗: From induction of anesthesia until the end of surgery
The primary outcome is intraoperative oxygenation assessed by the arterial partial pressure of oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratio during mechanical ventilation.
次要结局
- Dynamic Lung Compliance(From induction of anesthesia until the end of surgery)
- Static Lung Compliance(From induction of anesthesia until the end of surgery)
- Peak Airway Pressure(From induction of anesthesia until the end of surgery)
- Plateau Airway Pressure(From induction of anesthesia until the end of surgery)
研究者
Mahmut Sami TUTAR
Associate Professor, Department of Anesthesiology and Reanimation
Konya City Hospital