Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
研究概览
简要总结
Lung-protective ventilation (LPV) during general anesthesia can trigger the development of early postoperative pulmonary complication (PPC) and ventilator associated lung injury. One of the proven components of the LPV is low tidal volume (TV). Data on the positive end-expiratory pressure (PEEP) parameters adjustment in laparoscopic surgery, as well as the effects on the respiratory biomechanics, lung tissue and respiratory muscles damage are limited and not clear.
The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.
详细描述
During laparoscopic surgery pressure on alveoli increases, due to in the conditions of pneumoperitoneum, muscle relaxation, the patient's position on the operating table, excess body weight and other factors. As the consequence, the alveoli collapse due to negative transpulmonary pressure. The personalized PEEP adjustment for each particular patient during laparoscopic surgery can help to avoid the adverse effects on biomechanical parameters of the respiratory system, the early PPC incidence and improve overall patients' recovery.
The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.
Investigators will measure if PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) versus PEEP constantly set at 5 cmH2O (control group) gives better outcomes and prevent the early PPC incidence in hospitals.
After the induction, intubation and insertion of the esophageal balloon catheter, TV for patients both groups is set to 6 ml / kg BMI: for men (50+0.91* (height-152.4), for women (45+0.91* (height-152.4); minute ventilation (MV) to ensure the level of PetCO2 - 30-35 mmHg, respiratory rate (RR) 15-25/min (maximum up to 35/min).
Gas exchange parameters including partial pressures of oxygen (PaO2) and carbon dioxide (PaCO2) in arterial blood will be measured before the induction (T0), after 1 hour after surgery (T5) and after 24 hours after surgery (T6), then will calculate PAO2/FiO2 respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III
排除标准
- •pregnancy
- •age less than 18 or more than 70 years
- •patients ASA > III
- •life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg despite norepinephrine at a dose > 2 μg/kg/min
- •primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumor metastases in the lungs
- •chronic decompensated diseases with extrapulmonary organ dysfunction (tumor progression, liver cirrhosis, congestive heart failure)
- •Glasgow coma score < 14
- •upper airways obstruction
结局指标
主要结局
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
时间窗: 5 minutes before intubation,1 hour after surgery, 24 hour after surgery
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups
次要结局
- Dynamics of the partial pressure of CO2 in exhaled gas(5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position)
- Dynamics of the respiratory biomechanics(5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position)
- Dynamics of the volume of CO2 eliminated per minute(5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position)
- Dynamics of the end-expiratory lung volume(5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position)
- Dynamics of the hemodynamic parameters(5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position)