A randomized control trial to compare the effect of conventional and individualized peak end expiratory pressure on kinetics of inflammatory biomarkers in obese patients undergoing laparoscopic surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean/median of change in level of interleukin 6 and surfactant protein D from baseline to post operative day 1 in conventional PEEP vs individualised PEEP in obese patients undergoing laparoscopic surgery
研究概览
简要总结
Globally there is an increase in the incidence of obesity and according to WHO, more than 650 million people were obese in 2016 leading to a proportionate rise in number of obese patients undergoing surgical procedures.Under general anaesthesia and paralysis there is a decrease in lung compliance and functional residual capacity (FRC) with loss of diaphragmatic tone leading to decrease in oxygen reserve and ventilation-perfusion mismatch. Pneumoperitoneum created for laparoscopic surgery causes a cephalic shift of diaphragm and elevates pleural pressure which increases lung atelectasis and the risk of post operative pulmonary complications(PPCs). The incidence of PPCs in obese patients (18-23%) is almost twice that of normal population. It is widely known that PPCs cause a significant increase in the length of Intensive care unit (ICU) and hospital stay.
The plasma kinetics of inflammation and lung injury biomarkers such as IL-6, SP-D,TNF-α, IL-8, sRAGE, CC-16, and KL6 help in identifying patients at risk of developing PPCs but the change in the level depends upon various factors such as preoperative lung condition and intra-operative ventilatory settings. Various lung protective stratergies have been suggested to decrease postoperative pulmonary atelectasis such as low tidal volumes (VT), individualized positive end-expiratory pressure (PEEP), recruitment manoeuvre (RM).
PEEP is the alveolar pressure above atmospheric pressure that exists at the end of expiration. Various advantages of PEEP are increase in lung compliance, prevention of alveolar collapse, improvement of oxygen diffusion thereby improving pulmonary dynamics and gas exchange. However, PEEP has certain adverse effects such as overdistention of alveoli (barotrauma), decrease in the cardiac output, unintended respiratory alkalosis. Many approaches to titrate PEEP have been proposed such as using PEEP tables (high or low), measuring compliance (static or dynamic), plateau pressure, pressure-volume curve and inflection points and esophageal balloons to measure transpulmonary pressure.
PPCs can be considered as a composite outcome measure which includes respiratory infection, respiratory failure, plueral effusion, atelectasis, etc as per European Perioperative Clinical Outcome(EPCO). Post operative pulmonary atelectasis is best identified using various imaging modalities such as CT, ultrasound or electric impedance tomography but may not be always feasible for every patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Body Mass Index (BMI)≥30kg/m2 and American Society of Anesthesiologists (ASA) Physical Status I–III, undergoing laparoscopic general surgery of 2-4 hours duration.
排除标准
- •Patients with history of any lung disease.
- •Recent infections, recent ventilatory support.
- •Use of immunosuppressive medication.
- •History of smoking in the past 8 weeks.
结局指标
主要结局
Mean/median of change in level of interleukin 6 and surfactant protein D from baseline to post operative day 1 in conventional PEEP vs individualised PEEP in obese patients undergoing laparoscopic surgery
时间窗: Post operative day 1
次要结局
- Proportion of patients developing post op pulmonary complications in the two groups(Correlation between the kinetics of inflammatory bio markers and occurrence of post operative pulmonary complications)
研究者
Garima Agrawal
Lady Hardinge Medical College
