Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.
Trials. 2020 Jul 6;21(1):618. doi: 10.1186/s13063-020-04565-y.
Obese patients undergoing general anesthesia and mechanical ventilation during laparoscopic abdominal surgery commonly have a higher incidence of postoperative pulmonary complications (PPCs), due to factors such as decreasing oxygen reserve, declining functional residual capacity, and reducing lung compliance. Pulmonary atelectasis caused by pneumoperitoneum and mechanical ventilation is further aggravated in obese patients. Recent studies demonstrated that individualized positive end-expiratory pressure (iPEEP) was one of effective lung-protective ventilation strategies. However, there is still no exact method to determine the best iPEEP, especially for obese patients. Here, we will use the best static lung compliance (Cstat) method to determine iPEEP, compared with regular PEEP, by observing the atelectasis area measured by electrical impedance tomography (EIT), and try to prove a better iPEEP setting method for obese patients.
This study is a single-center, two-arm, prospective, randomized control trial. A total number of 80 obese patients with body mass index ≥ 32.5 kg/m scheduled for laparoscopic gastric volume reduction and at medium to high risk for PPCs will be enrolled. They will be randomly assigned to control group (PEEP5 group) and iPEEP group. A PEEP of 5 cmHO will be used in PEEP5 group, whereas an individualized PEEP value determined by a Cstat-directed PEEP titration procedure will be applied in the iPEEP group. Standard lung-protective ventilation methods such as low tidal volumes (7 ml/kg, predicted body weight, PBW), a fraction of inspired oxygen ≥ 0.5, and recruitment maneuvers (RM) will be applied during and after operation in both groups. Primary endpoints will be postoperative atelectasis measured by chest electrical impedance tomography (EIT) and intraoperative oxygen index. Secondary endpoints will be serum IL-6, TNF-α, procalcitonin (PCT) kinetics during and after surgery, incidence of PPCs, organ dysfunction, length of in-hospital stay, and hospital expense.
Although there are several studies about the effect of iPEEP titration on perioperative PPCs in obese patients recently, the iPEEP setting method they used was complex and was not always feasible in routine clinical practice. This trial will assess a possible simple method to determine individualized optimal PEEP in obese patients and try to demonstrate that individualized PEEP with lung-protective ventilation methods is necessary for obese patients undergoing general surgery. The results of this trial will support anesthesiologist a feasible Cstat-directed PEEP titration method during anesthesia for obese patients in attempt to prevent PPCs.
www.chictr.org.cn ChiCTR1900026466. Registered on 11 October 2019.
肥胖患者在接受腹腔镜腹部手术全身麻醉和机械通气时,由于氧储备减少、功能残气量下降和肺顺应性降低等因素,术后肺部并发症(PPCs)的发生率较高。肥胖患者中,由于气腹和机械通气引起的肺不张进一步加重。最近的研究表明,个体化呼气末正压(iPEEP)是一种有效的肺保护通气策略。然而,仍然没有确定最佳 iPEEP 的精确方法,特别是对于肥胖患者。在这里,我们将使用最佳静态肺顺应性(Cstat)方法来确定 iPEEP,与常规 PEEP 相比,通过观察电气阻抗断层扫描(EIT)测量的肺不张面积,并尝试为肥胖患者证明一种更好的 iPEEP 设置方法。
这是一项单中心、两臂、前瞻性、随机对照试验。将纳入 80 名肥胖患者,体重指数≥32.5kg/m²,计划接受腹腔镜胃容量减少术,且 PPCs 风险处于中高等级。他们将被随机分配到对照组(PEEP5 组)和 iPEEP 组。PEEP5 组使用 PEEP 5cmH2O,而 iPEEP 组则使用通过 Cstat 指导的 PEEP 滴定程序确定的个体化 PEEP 值。两组均在术中及术后应用标准肺保护通气方法,如小潮气量(7ml/kg,预测体重)、吸氧分数≥0.5 和复张手法(RM)。主要终点是通过胸部电气阻抗断层扫描(EIT)测量术后肺不张,以及术中氧指数。次要终点是手术期间和手术后血清白细胞介素 6、肿瘤坏死因子-α、降钙素原(PCT)动力学、PPCs 发生率、器官功能障碍、住院时间和住院费用。
尽管最近有几项关于肥胖患者 iPEEP 滴定对围手术期 PPCs 影响的研究,但他们使用的 iPEEP 设置方法较为复杂,在常规临床实践中并不总是可行。本试验将评估一种确定肥胖患者个体化最佳 PEEP 的可能简单方法,并尝试证明肥胖患者接受全身麻醉时使用个体化 PEEP 和肺保护通气方法是必要的。该试验的结果将为麻醉师提供一种可行的 Cstat 指导的 PEEP 滴定方法,以试图预防 PPCs。
www.chictr.org.cn ChiCTR1900026466. 注册于 2019 年 10 月 11 日。