Evaluation of Regional Lung Mechanics in Obese Patients Undergoing Laparoscopic Surgery Using Electrical Impedance Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Best Positive end-expiratory pressure - Laparoscopy variability
研究概览
简要总结
This study will evaluate what is the impact of laparoscopy and Trendelenburg position on lung regional ventilation distribution in obese patients, focusing on the differences between the different phases of surgery.
详细描述
Electrical impedance tomography (EIT) is a non invasive monitoring technique that allows to evaluate the regional distribution of ventilation. EIT has been used in different contexts, such as acute respiratory failure or intraoperative ventilation settings. Obesity, by increasing intrabdominal pressure, may reduce functional residual capacity after anesthesia and therefore require a more aggressive intraoperative ventilatory setting. In addition, laparoscopy, by increasing the volume of the abdomen, further pushes the diaphragm and increase the probability of lung collapse.
The aim of the current study is to describe the effect of 1) anesthesia and of 2) laparoscopy and trendelenburg position on regional ventilation distribution. Moreover, the investigators will evaluate if the best ventilatory parameters set after anesthesia induction are confirmed also when the condition changes (i.e. during pneumoperitoneum and trendellenburg).
Finally, the investigators will explore if the different parameters which can be provided by EIT agree in suggesting the best level of positive-end expiratory pressure in both moments of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-90 years
- •Body mass index > 30 kg/m2
- •Major surgery
- •Predicted duration of surgery > 2 hours
- •Predicted presence of invasive arterial pressure monitoring
排除标准
- •emergency surgery
- •Refuse to participate from patient
- •presence of Implantable cardiac device or pacemaker
- •thoracic wounds
- •thoracic surgery
研究组 & 干预措施
Single arm intervention
All patients will undergo a PEEP titration trial in each surgery step (before pneumoperitoneum, during pneumoperitoneum, after pneumoperitoneum). The PEEP titration trial will be done in steps of 2 cmH2O, starting from clinical PEEP 16 cmH2O and ending to PEEP 6 cmH2O. Each PEEP level will be kept for 2 minutes. The PEEP titration trial will be stopped in case of haemodynamic instability or severe desaturation (Spo2 < 92%). Each PEEP titration trial will be recorded using Electrical impedance tomography (EIT).
干预措施: PEEP titration trial (Procedure)
结局指标
主要结局
Best Positive end-expiratory pressure - Laparoscopy variability
时间窗: Difference between the best PEEP after anesthesia induction and during pneumoperitoneum
The primary outcome will be the best PEEP found using the PEEP titration trial.
次要结局
- Best Positive end-expiratory pressure - EIT variability(After anesthesia induction, during pneumoperitoneum, end of surgery)
研究者
Savino Spadaro
Clinical Professor
Università degli Studi di Ferrara