The Comparison of Pressure-controlled Ventilation and Pressure-controlled Ventilation Volume-guaranteed on Respiratory Dynamics and Clinical Outcome in Patients Undergoing Bariatric Surgery: Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dynamic lung compliance measure
研究概览
简要总结
This study compares the two mechanical ventilation strategies in obese patients undergoing bariatric surgery: pressure-controlled ventilation(PCV) and pressure-controlled ventilation volume-guaranteed（PCV-VG). This is a randomized controlled trial with a sample size of 100 patients whose body mass index(BMI) is over 30kg/m².
详细描述
With the development of economy and changing of life style, obesity is becoming a common phenomenon. More and more obese patients are undergoing bariatric surgery every year.
Obesity results in a series of physiological changes particularly the respiratory system. The decrease of lung compliance and the limited total lung capacity, vital capacity, functional residual capacity are all contributed to intraoperative hypoxemia and postoperative lung complications. Presently study mainly discuss lung protective ventilation strategies from four aspects: tidal volume,ventilation modes,positive end-expiratory pressures and lung recruitment maneuvers.
This prospective study will compare two ventilation modes in obese patients undergoing bariatric surgery:pressure-controlled ventilation(PCV) and pressure-controlled ventilation volume-guaranteed（PCV-VG).
The total of 100 patients will be divided into two groups randomly. The patients will be ventilated with PCV or PCV-VG modes plus positive end expiratory pressure (PEEP) of 5cmH2O throughout the whole operation.
The respiratory and hemodynamic parameters in six time points will be recorded, and the postoperative chest computerized tomography (CT) will be checked to identify the postoperative lung complications.
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
- Double (Participant, Outcomes Assessor)
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
- •BMI≥30kg/m²
- •ASA classification II-III
- •Bariatric surgery
排除标准
- •Patients combined restrictive or obstructive lung diseases,pneumonia, bullae of lung ; patients after pneumonectomy
- •Patients combined with other severe internal medicine diseases
- •duration of pregnancy or suckling
研究组 & 干预措施
PCV-VG+PEEP5cmH₂O
Patients in this group are ventilated with pressure-controlled ventilation volume-guaranteed mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.
干预措施: PCV-VG, PEEP5cmH₂O (Device)
PCV+PEEP5cmH₂O
Patients in this group are ventilated with pressure-controlled ventilation mode. And we use PEEP of 5cmH₂O to open the collapsed alveoli.
干预措施: PCV, PEEP5cmH₂O (Device)
结局指标
主要结局
Dynamic lung compliance measure
时间窗: three hours
Dynamic lung compliance can be calculated based on tidal volume,peak inspiratory pressure and PEEP. 10minutes after induction,10minutes after pneumoperitoneum,60minutes after pneumoperitoneum and 10minutes after pneumoperitoneum release will be recorded.
次要结局
- the risk factors of postoperative lung complications(five days)
- Postoperative lung complications(five days)
研究者
Wu Pan
Principal Investigator
Huashan Hospital