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[JAMA发表论文]:肥胖患者术中使用高PEEP和肺复张不能减少术后呼吸系统并发症
2019年06月20日 时讯速递, 进展交流 暂无评论

Original Investigation

Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial

Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology

JAMA. 2019;321(23):2292-2305. doi:10.1001/jama.2019.7505

Abstract 摘要

Importance 背景

An intraoperative higher level of positive end-expiratory positive pressure (PEEP) with alveolar recruitment maneuvers improves respiratory function in obese patients undergoing surgery, but the effect on clinical outcomes is uncertain.

术中高PEEP和肺复张能够改善肥胖患者的呼吸功能,但是对临床预后的影响并不明确。

Objective 目的

To determine whether a higher level of PEEP with alveolar recruitment maneuvers decreases postoperative pulmonary complications in obese patients undergoing surgery compared with a lower level of PEEP.

确定与低PEEP相比,高PEEP和肺复张能否减少肥胖患者术后肺部并发症

Design, Setting, and Participants 试验设计,场景和研究人群

Randomized clinical trial of 2013 adults with body mass indices of 35 or greater and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia. The trial was conducted at 77 sites in 23 countries from July 2014-February 2018; final follow-up: May 2018.

这项随机临床试验纳入了2013名BMI不低于35且具有很高术后肺部并发症风险的患者,所有患者均在全麻下接受非心脏、非神经系统手术。试验于2014年7月至2018年2月间在23个国家77个中心进行,最后随访日期为2018年5月。

Interventions 干预措施

Patients were randomized to the high level of PEEP group (n = 989), consisting of a PEEP level of 12 cm H2O with alveolar recruitment maneuvers (a stepwise increase of tidal volume and eventually PEEP) or to the low level of PEEP group (n = 987), consisting of a PEEP level of 4 cm H2O. All patients received volume-controlled ventilation with a tidal volume of 7 mL/kg of predicted body weight.

患者接受随机分组,高PEEP组(n = 989)接受12 cm H2O的PEEP,以及肺复张操作(逐渐增加潮气量及PEEP),低PEEP组(n = 987)接受4 cm H2O的PEEP。所有患者均接受容量控制通气,潮气量7 mL/kg理想体重。

Main Outcomes and Measures 主要预后指标

The primary outcome was a composite of pulmonary complications within the first 5 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonary infiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax. Among the 9 prespecified secondary outcomes, 3 were intraoperative complications, including hypoxemia (oxygen desaturation with Spo2 ≤92% for >1 minute).

主要预后指标为复合指标,即术后5天内发生的肺部并发症,包括呼吸功能衰竭、ARDS、支气管痉挛、新发肺部浸润影、肺部感染、吸入性肺炎、胸腔积液、肺不张、心源性肺水肿和气胸。在预先确定的9项次药指标中,3项为包括低氧血症(氧饱和度Spo2 ≤ 92% 持续 > 1 分钟)在内的术中并发症。

Results 结果

Among 2013 adults who were randomized, 1976 (98.2%) completed the trial (mean age, 48.8 years; 1381 [69.9%] women; 1778 [90.1%] underwent abdominal operations). In the intention-to-treat analysis, the primary outcome occurred in 211 of 989 patients (21.3%) in the high level of PEEP group compared with 233 of 987 patients (23.6%) in the low level of PEEP group (difference, −2.3% [95% CI, −5.9% to 1.4%]; risk ratio, 0.93 [95% CI, 0.83 to 1.04]; P = .23). Among the 9 prespecified secondary outcomes, 6 were not significantly different between the high and low level of PEEP groups, and 3 were significantly different, including fewer patients with hypoxemia (5.0% in the high level of PEEP group vs 13.6% in the low level of PEEP group; difference, −8.6% [95% CI, −11.1% to 6.1%]; P < .001).

在接受随机分组的2013名成年患者中,1976名 (98.2%) 患者完成临床试验(平均年龄,48.8 岁;1381名 [69.9%] 女性患者;1778名 [90.1%] 患者接受腹部手术)。在意向治疗分析中,高PEEP组989名患者中211名(21.3%)患者以及低PEEP组987名患者中233名患者(23.6%)满足主要预后终点(差异,−2.3% [95% CI, −5.9% to 1.4%];风险比,0.93 [95% CI, 0.83 to 1.04]; P = .23)。在9项预先确定的次要预后终点中,高PEEP组与低PEEP组间6项指标无显著差异,3项指标具有显著差异,包括低氧血症患者比例降低(高PEEP组5.0% vs 低PEEP组13.6%;差异,−8.6% [95% CI, −11.1% to 6.1%]; P < .001)。

Conclusions and Relevance 结论与意义

Among obese patients undergoing surgery under general anesthesia, an intraoperative mechanical ventilation strategy with a higher level of PEEP and alveolar recruitment maneuvers, compared with a strategy with a lower level of PEEP, did not reduce postoperative pulmonary complications.

对于接受全麻手术的肥胖患者,术中采用高PEEP及肺复张的机械通气策略,与低PEEP策略相比,不能减少术后肺部并发症。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT02148692

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