Flow-Controlled Versus Volume-Controlled Ventilation in Lumbar Disc Herniation Surgery
Comparison of Flow-Controlled and Volume-Controlled Ventilation During Lumbar Disc Herniation Surgery: A Prospective Randomized Trial
This prospective randomized trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on intraoperative airway pressures and oxygenation in patients undergoing lumbar disc herniation surgery under general anesthesia.
Adult patients aged 18-65 years, with ASA physical status I-III and a body mass index of 18-30 kg/m², will be allocated to receive either FCV or VCV during routine intraoperative mechanical ventilation. Ventilatory parameters, including peak airway pressure, plateau pressure, pulmonary compliance, EtCO₂, SpO₂, and arterial blood gas variables, will be recorded at predefined time points after intubation.
The primary endpoint is the PaO₂ value measured after 20 minutes in the prone position.
By comparing respiratory mechanics and oxygenation between the two ventilation modes, this study aims to contribute to the optimization of intraoperative ventilatory management in lumbar disc herniation surgery.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Atakan Sezgi
- 电话号码：00905323327000
- 邮箱：kansezgi@gmail.com
研究联系人备份
- 姓名：Musa Zengin
- 电话号码：00905307716235
- 邮箱：musazengin@gmail.com
学习地点
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Ankara、土耳其（türkiye）、06170
- 招聘中
- Ankara Etlik City Hospital
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接触：
- Jülide Ergil, Professor
- 电话号码：00905323469216
- 邮箱：julideergil@hotmail.com
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接触：
- Atakan Sezgi, M.D.
- 电话号码：00905323327000
- 邮箱：kansezgi@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age between 18 and 65 years
- ASA physical status I-III
- Body Mass Index between 18 and 30 kg/m²
Exclusion Criteria:
- Age < 18 years or > 65 years
- Known or previously diagnosed pulmonary disease
- Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ < 50% predicted, severe restrictive or obstructive pathology)
- Patients with markedly altered lung anatomy or function due to prior major thoracic surgery
- Patients who were dependent on supplemental oxygen therapy in the preoperative period
- ASA physical status IV or higher
- Refusal or inability to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：VCV集团
分配到VCV组的患者将在全身麻醉下，在整个手术期间接受使用传统容量控制通气模式的术中机械通气。
麻醉诱导、监测和围手术期管理将遵循与FCV组相同的标准化临床方案。
将在相同的预定术中时间点收集通气参数，包括峰值和平台气道压力以及动脉血气测量值。
该组作为比较组，用于评估容量控制通气对这些患者气道压力和氧合的影响。
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分配到VCV组的患者将在全身麻醉下手术期间接受使用传统容量控制通气模式的术中机械通气。
患者将在插管后开始通气，参数设置为：50%氧气、7毫升/理想体重潮气量、5 PEEP、每分钟12次呼吸频率，以及1:2的吸呼比。
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有源比较器：FCV Group
Patients allocated to the FCV group will receive intraoperative mechanical ventilation using a flow-controlled ventilation mode during surgery under general anesthesia. %50 FiO₂ will be applied, and a driving pressure of 12 cmH₂O will be used. After intubation, the patient will be placed in the prone position. Following the prone position, the patient's FiO₂ will be maintained between 0.8 and 1.0 for 20 minutes. After the 20th minute, ventilator settings will be returned to the baseline values. Tidal volume will be generated and recorded by the ventilator according to the driving pressure and the patient's lung mechanics. Minute ventilation will be adjusted based on the target tidal volume. The target tidal volume will be set at 6-8 mL/kg (7 mL/kg) with a respiratory rate of 12 breaths/min. Positive end-expiratory pressure (PEEP) will be maintained at 5 cmH₂O. The respiratory rate will be further titrated to maintain ETCO₂ between 35 and 40 mmHg. |
分配到FCV组的患者将在全身麻醉手术期间接受使用流量控制通气模式的术中机械通气。
患者将在插管后开始通气，使用50%氧气，驱动压力12，PEEP 5，以及1:1的吸气/呼气比。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The PaO₂ measured 20 minutes after prone position.
大体时间：20 minutes after the prone position, in the intraoperative period.
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The primary outcome measure will be the PaO₂ derived from arterial blood gas analysis at 20 minutes after the prone position.
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20 minutes after the prone position, in the intraoperative period.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The PaO₂ measured during perioperative period
大体时间：Day 1
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The PaO₂ values will be measured and recorded using arterial blood gas analysis.
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Day 1
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Peak airway pressure (Ppeak) values during perioperative period
大体时间：Day 1
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Ppeak will be measured and recorded.
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Day 1
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Plateau airway pressure (Pplateau) values during perioperative period
大体时间：Day 1
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Pplateau will be measured and recorded.
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Day 1
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AEŞH-EK-2026-096
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