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胃超声评估术前碳水化合物饮料的胃排空:一项随机对照非劣效性研究
BACKGROUND: Tools for the evaluation of gastric emptying(胃排空) have evolved over time. The purpose of this study was to show that the risk of pulmonary aspiration(肺误吸) is not increased with carbohydrate drink, by demonstrating that the gastric antral cross-sectional area (CSA)(胃窦横截面积) of the NO-NPO group is either equivalent to or less than that of the NPO (nil per os) group.
背景:评估胃排空的工具随着时间的推移而发展。本研究的目的是通过证明NO-NPO组的胃窦横截面积(CSA)等于或小于NPO组，来证明碳水化合物饮料不会增加肺误吸的风险。
METHODS: Sixty-four patients scheduled for elective laparoscopic(腹腔镜的)benign(良性的) gynecologic(妇产科医学的) surgery were enrolled and randomly assigned to the NPO group (n = 32) or the NO-NPO group (n = 32). After having a regular meal until midnight before surgery, the NPO group fasted(禁食)until surgery, while the NO-NPO group ingested 400 mL of a carbohydrate drink at midnight and freely up to 2 hours before anesthesia. The primary outcome was the gastric antral CSA by gastric ultrasound（胃部超声) in right lateral decubitus position (RLDP)（右侧卧位). Noninferiority was defined as a mean difference of CSA <2.8cm2. Secondary outcomes included CSA in supine position, gastric volume (GV), GV per weight (GV/kg), GV/kg >1.5ml/kg, and Perlas grade.
方法:选择64例择期腹腔镜良性妇科手术患者，随机分为NPO组(n = 32)和NO-NPO组(n = 32)。NPO组在术前正常进食至午夜后禁食至手术，而NO-NPO组在午夜进食400毫升碳水化合物饮料，并在麻醉前2小时自由进食。主要观察结果为右侧卧位(RLDP)胃超声胃窦CSA。非劣效性定义为CSA <2.8 cm2的平均差。次要结果包括仰卧位CSA、胃容积(GV)、单位重量的GV (GV/kg)、GV/kg >1.5 mL/kg和Perlas级。
图1 胃窦部横截面积测量代表图
显示CSA在2个垂直方向上直径的测量
表1 患者的基线特征
数据以平均标准偏差、中位数(四分位范围)或数字(%)表示
图2 此研究流程图
表2 胃窦CSA, Perlas分级，胃体积，胃超声评估危险胃发生率
数据以平均标准偏差、中位数(四分位范围)或数字(%)表示
图3 NPO组与NO-NPO组右侧卧位胃窦部横截面积平均差的非劣效图
虚线表示非劣效边界(Δ)。误差条表示横截面面积差异(NO-NPO组−NPO组)的95% CI。该图描述了两组之间的非劣效性(等效性)
RESULTS: CSA in RLDP was not different between the NPO group (6.25 ± 3.79cm2) and the NO-NPO group (6.21 ± 2.48 cm2; P=.959). The mean difference of CSA in RLDP (NO-NPO group − NPO group) was 0.04 (95%l [CI],−1.56 to 1.64), which was within the noninferiority margin of 2.8 cm2. CSA was not different between the 2 groups (4.17 ± 2.34cm2 in NPO group versus 4.28 ± 1.23cm2 in NO-NPO group; P=.828). GV in NPO group (70 ± 56 mL) was not different from NO-NPO group (66 ± 36 mL; mean difference,3.66; 95%CI,−20 to 27; P=.756). GV/kg in the NPO group (1.25±1.00mL/kg) was not different from the NO-NPO group (1.17±0.67mL/kg;P=.694). The incidence of GV/kg > 1.5 mL/kg was not different between NPO (31.3%) and NO-NPO group (21.9%;P=.768). The median (interquartile range) of the Perlas grade was 1 (0–1) in NPO group and 0.5 (0–1) in NO-NPO group (P=.871).
结果:RLDP CSA在NPO组(6.25±3.79cm2)和NO-NPO组(6.21±2.48cm2)之间无显著性差异;P=.959)。RLDP (NO-NPO组-NPO组)CSA的平均差为0.04, 95%[CI]:−1.56-1.64)，在2.8 cm2的非劣势范围内。两组间CSA无差异(NPO组为4.17±2.34 cm2, NO-NPO组为4.28±1.23cm2;P=.828)。NPO组GV(70±56 mL)与NO-NPO组(66±36 mL)无明显差异;平均差,3.66;95% Cl:20-27,P=.756) NPO组GV/kg(1.25±1.00mL/kg)与NO-NPO组GV/kg(1.17±0.67 mL/kg)无显著差异;P=.694)。Perlas分级的中位数(四分位数范围)在NPO组为1 (0-1)，在NO-NPO组为0.5 (0-1)(P=.871)。
CONCLUSIONS:Preoperative carbohydrates ingested up to 2 hours before anesthesia do not delay gastric emptying compared to midnight fasting(午夜禁食), as evaluated with gastric ultrasound.
结论:根据胃超声评估，与午夜禁食相比，麻醉前2小时摄入碳水化合物不会延迟胃排空。
词汇表：ASA =美国麻醉学家学会; BMI =体重指数;联盟=综合报告试验标准; ci =置信区间; CSA =横截面积; GV =胃体积; ICC =脑内相关系数; IQS =图像质量分数; IVC =下腔静脉; l =肝脏; LD =最长直径;每个OS的NPO = NIL; p =胰腺; RLDP =右侧褥疮位置; SD =最短直径; SMD =标准化平均差异; SPSS =社会科学的统计包
学习笔记
1
医学术语
gastric 胃的
gastric emptying 胃排空
gastric volume 胃体积
gastric ultrasound assessing胃超声评估
gastric antral 胃窦
cross-sectional area 横截面积
pulmonary 肺部的
pulmonary aspiration 肺误吸
laparoscope 腹腔镜
laparoscopic 腹腔镜的
gynecology 妇产科
gynecologic妇产科医学的
fast 禁食
midnight fasting 午夜禁食
ingest 摄取
right lateral decubitus position 右侧卧位
decubitus 褥疮；卧位
supine position 仰卧位
2
知识扩展
非劣效性试验：一种随机对照临床试验（RCT）。在这种试验中，研究者将一种新的治疗方法与一种标准的有活性的疗法（不是与安慰剂或不进行治疗的对照组）进行比较，试图证实新治疗方法的疗效不比对照疗法差。当预期一种新药与对比药有相似有效性但同时能提供某些比对照药优越之处时，可以采用非劣效性试验。
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