Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.
Trials. 2021 Oct 15;22(1):704. doi: 10.1186/s13063-021-05671-1.
The incidence of postoperative pulmonary complications (PPCs) is higher in obese patients undergoing general anesthesia and mechanical ventilation due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. Individualized positive end-expiratory pressure (iPEEP) along with other lung-protective strategies is effective in alleviating postoperative atelectasis. Here, we compared the best static lung compliance (Cstat) titration of iPEEP with electrical impedance tomography (EIT) titration to observe their effects on postoperative atelectasis in obese patients undergoing laparoscopic surgery.
A total number of 140 obese patients with BMI ≥ 32.5kg/m undergoing elective laparoscopic gastric volume reduction and at moderate to high risk of developing PPCs will be enrolled and randomized into the optimal static lung compliance-directed iPEEP group and EIT titration iPEEP group. The primary endpoint will be pulmonary atelectasis measured and calculated by EIT immediately after extubation and 2 h after surgery. Secondary endpoints will be intraoperative oxygenation index, organ dysfunction, incidence of PPCs, hospital expenses, and length of hospital stay.
Many iPEEP titration methods effective for normal weight patients may not be appropriate for obese patients. Although EIT-guided iPEEP titration is effective in obese patients, its high price and complexity limit its application in many clinical facilities. This trial will test the efficacy of iPEEP via the optimal static lung compliance-guided titration procedure by comparing it with EIT-guided PEEP titration. The results of this trial will provide a feasible and convenient method for anesthesiologists to set individualized PEEP for obese patients during laparoscopic surgery.
ClinicalTrials.gov ChiCTR2000039144 . Registered on October 19, 2020.
全身麻醉和机械通气的肥胖患者由于氧储备、功能残气量和肺顺应性降低,术后肺部并发症(PPCs)的发生率更高。个体化呼气末正压(iPEEP)联合其他肺保护策略可有效缓解术后肺不张。本研究比较了 iPEEP 的最佳静态肺顺应性(Cstat)滴定与电阻抗断层成像(EIT)滴定,观察其对腹腔镜手术肥胖患者术后肺不张的影响。
将 140 例 BMI≥32.5kg/m2的择期行腹腔镜胃容量减少术且中高危 PPCs 肥胖患者纳入研究并随机分为最佳静态肺顺应性指导 iPEEP 组和 EIT 滴定 iPEEP 组。主要终点为术后即刻和术后 2h 经 EIT 测量和计算的肺不张。次要终点为术中氧合指数、器官功能障碍、PPCs 发生率、住院费用和住院时间。
许多适用于正常体重患者的 iPEEP 滴定方法可能不适用于肥胖患者。尽管 EIT 指导的 iPEEP 滴定对肥胖患者有效,但因其价格高且操作复杂限制了其在许多临床场所的应用。本试验将通过比较最佳静态肺顺应性指导的 iPEEP 滴定与 EIT 指导的 PEEP 滴定,来验证 iPEEP 的疗效。该试验的结果将为麻醉医生在腹腔镜手术中为肥胖患者设定个体化 PEEP 提供一种可行且方便的方法。
ClinicalTrials.gov ChiCTR2000039144,于 2020 年 10 月 19 日注册。