Flow- Versus Volume-controlled Ventilation During Robot-assisted Laparoscopic Radical Prostatectomy
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ankara Etlik City Hospital
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)
概览
简要总结
During robot-assisted laparoscopic radical prostatectomy (RALRP), patients are placed under general anesthesia and supported with mechanical ventilation. In this study, the effects of two different ventilatory strategies-flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV)-were compared. Using electrical impedance tomography (EIT) to provide real-time assessment of lung status and to guide individualized positive end-expiratory pressure (PEEP) settings, we investigated whether FCV offers superior oxygenation and improved respiratory system mechanics compared with VCV.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients aged 18 years or older
- •American Society of Anesthesiologists physical status (ASA-PS) class I-III
- •Scheduled for robot-assisted laparoscopic radical prostatectomy (RALRP)
- •Provided written informed consent to participate in the study
排除标准
- •Patients who declined to participate or withdrew consent
- •Conversion from robot-assisted laparoscopic radical prostatectomy to open surgery
- •Reoperation within 7 days postoperatively
- •Chronic pulmonary disease
- •Implanted cardiac devices
- •Congestive heart failure New York Heart Association III/IV
- •Severe haemodynamic instability after induction of anaesthesia
研究组 & 干预措施
Flow-controlled ventilation (FCV)
Patients received intraoperative mechanical ventilation using flow-controlled ventilation during robot-assisted laparoscopic radical prostatectomy. Positive end-expiratory pressure (PEEP) was individualized using electrical impedance tomography (EIT) following a standardized titration protocol.
干预措施: Flow-Controlled Ventilation (Device)
Volume-controlled ventilation (VCV)
Patients received intraoperative mechanical ventilation using volume-controlled ventilation during robot-assisted laparoscopic radical prostatectomy. Positive end-expiratory pressure (PEEP) was individualized using electrical impedance tomography (EIT) following the same standardized titration protocol.
干预措施: Volume-Controlled Ventilation (Device)
结局指标
主要结局
The ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2)
时间窗: During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).
The primary outcome is the PaO2/FiO2 before extubation (T4).
次要结局
- Driving pressure(During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).)
- Mechanical power(During the intraoperative period at four predefined time points: after induction of general anesthesia (T1), after pneumoperitoneum and Trendelenburg positioning (T2), 60 minutes after T2 (T3), and before extubation (T4).)
- Lung ultrasound score(Lung ultrasound scores (LUS) are assessed at two time points: immediately before anesthesia induction and on the first postoperative day.)
- pulmonary/extrapulmonary complications(The first seven postoperative days)
研究者
Gokcen Kulturoglu
Medical doctor
Ankara Etlik City Hospital