Impact of Dynamic Compliance-guided Ventilation on Postoperative Pulmonary Function in Lumbar Stabilization Surgery:A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Modified Lung Ultrasound Score
研究概览
简要总结
Postoperative pulmonary complications are a frequent cause of morbidity following lumbar stabilization surgery. Conventional ventilation strategies may not adequately reflect intraoperative changes in respiratory mechanics, potentially leading to impaired postoperative pulmonary function. Dynamic compliance-guided ventilation provides a real-time, individualized approach by adjusting ventilatory parameters according to lung compliance.
This prospective randomized controlled study aims to evaluate the effects of dynamic compliance-guided ventilation compared with standard ventilation strategies on postoperative pulmonary function in patients undergoing lumbar stabilization surgery. Eligible patients will be randomly assigned to either the compliance-guided group or the conventional ventilation group.
In this study, the investigators aim to prospectively compare ventilation with the dynamic compliance (Cdyn) approach-one of the lung-protective ventilation strategies-with conventional ventilation methods in patients undergoing surgery in the prone position. The primary outcome will be evaluated using a modified lung ultrasound scoring system based on the most severely affected regions of aeration loss. Secondary objectives include the assessment of intraoperative hemodynamics, respiratory mechanics, and the effects on postoperative pulmonary function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Patients who will undergo lumbar stabilization in the prone position
排除标准
- •Patients with ASA classification IV or higher
- •Patients with obesity (BMI>30) or cachexia (BMI<18)
- •Allergy to standard medications used during general anesthesia
- •Contraindications to PEEP (high intracranial pressure, bronchopleural fistula, hypovolemic shock, right heart failure)
- •Previous lung surgery (any)
- •Known serious heart disease defined as New York Heart Association class III or higher
- •Patients with severe asthma and COPD
- •Acute myocardial infarction within the last 12 months before surgery
- •Neuromuscular disease
研究组 & 干预措施
Dynamic Compliance Guided Ventilation
Patients receive intraoperative ventilation adjusted according to real time dynamic compliance monitoring
干预措施: Dynamic Compliance Guided Ventilation (Procedure)
Standart Ventilation
Patients receive intraoperative ventilation based on conventional standart settings without dynamic compliance adjustment
干预措施: Standard Ventilation (Procedure)
结局指标
主要结局
Modified Lung Ultrasound Score
时间窗: baseline, postoperative 1th hour, postoperative 24th hour
The assessment will be performed using the Modified Lung Ultrasound Scoring system. The scale ranges from a minimum of 0 to a maximum of 36 points. A score of 0 indicates normal aeration in all zones, while a score of 36 represents the worst possible aeration loss. Higher scores indicate a worse outcome (increased lung aeration loss/atelectasis).
次要结局
- Incidence postoperative pulmonary complications(PPC)(postoperative first 7 days)
- Intraoperative Dynamic Compliance (Cdyn)(intraoperative)
- Intraoperative Plateau Pressure (Pplat)(intraoperative)
- Intraoperative Driving Pressure (ΔP)(intraoperative)
- Intraoperative Peak Pressure (Ppeak)(intraoperative)
- Mean arterial pressure(MAP)(Baseline,intraoperative,1st hour postoperatively.)
- Heart Rate(Baseline,intraoperative,1st hour postoperatively.)
- Length of stay(From date of surgery until date of hospital discharge)
- Partial pressure of oxygen(Baseline, intraoperative,1st hour postoperatively.)
- SPO2(Baseline,intraoperative,1st hour postoperatively.)
研究者
Burak NALBANT
Assistant Professor
Ankara City Hospital Bilkent