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喉罩气道导管(LMA)畅销产品的临床性能比较分析:小儿全身麻醉中盲插与米勒喉镜引导插入的双盲随机对照试验

Comparative analysis of LMA Blockbuster clinical performance: Blind versus Miller laryngoscope-guided insertion in paediatric general anaesthesia - A double-blinded, randomised controlled trial.

作者信息

Bihani Pooja, Jaju Rishabh, Paliwal Naveen, Janweja Sarita, Vyas Ankit

机构信息

Department of Anaesthesiology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India.

Department of Anaesthesiology, Jaipur National University Institute for Medical Sciences and Research Centre, Jaipur, Rajasthan, India.

出版信息

Indian J Anaesth. 2024 Oct;68(10):875-881. doi: 10.4103/ija.ija_186_24. Epub 2024 Sep 14.

Abstract

BACKGROUND AND AIMS

The second-generation supraglottic airway device is conventionally inserted blindly, which might result in suboptimal placement. Limited literature exists on under-vision insertion techniques, particularly in paediatric patients. The primary objective of this study was to compare the oropharyngeal leak pressure (OPLP) between the blind insertion of the LMA Blockbuster and the Miller laryngoscope-guided insertion in children. Secondary outcomes included the number of insertion attempts, haemodynamic disturbances, insertion time and airway complications.

METHODS

This randomised controlled trial study enroled 100 patients aged 1-4 years undergoing elective surgery. Patients were randomised into blind insertion (Group A) or Miller laryngoscope-guided insertion (Group B) of the LMA Blockbuster. The primary outcome measure was OPLP. Insertion time, haemodynamic changes and postoperative complications were also assessed. The Chi-square, Fisher's exact and -test were applied appropriately, with the significance level set at < 0.05.

RESULTS

Significantly higher mean OPLP was observed in Group B compared to Group A - 27.9 [standard deviation (SD): 1.58] cmHO versus 25.94 (SD: 0.63) cmHO [mean difference (MD): 1.96 (95% confidence interval {CI}: 1.48, 2.44; < 0.001)]. Mean insertion time was longer in Group B, that is, 11.9 (SD: 1.91) s versus 8.7 (SD: 0.6) s [MD: 3.2 s; (95% CI: 2.63, 3.76; < 0.001)]; however, the difference was not clinically relevant. First-attempt insertion, haemodynamic stability and postoperative complications were comparable ( > 0.05).

CONCLUSION

Miller laryngoscope-guided under-vision insertion of LMA Blockbuster improves alignment with epiglottic structures compared to blind insertion.

摘要

背景与目的

第二代声门上气道装置传统上是盲目插入,这可能导致放置不理想。关于可视下插入技术的文献有限,尤其是在儿科患者中。本研究的主要目的是比较在儿童中LMA Blockbuster盲目插入与米勒喉镜引导插入时的口咽漏气压(OPLP)。次要结局包括插入尝试次数、血流动力学紊乱、插入时间和气道并发症。

方法

这项随机对照试验研究纳入了100例年龄在1至4岁接受择期手术的患者。患者被随机分为LMA Blockbuster盲目插入组(A组)或米勒喉镜引导插入组(B组)。主要结局指标是OPLP。还评估了插入时间、血流动力学变化和术后并发症。适当应用卡方检验、费舍尔精确检验和t检验,显著性水平设定为P<0.05。

结果

与A组相比,B组观察到的平均OPLP显著更高——27.9[标准差(SD):1.58]cmH₂O对25.94(SD:0.63)cmH₂O[平均差值(MD):1.96(95%置信区间{CI}:1.48,2.44;P<0.001)]。B组的平均插入时间更长,即11.9(SD:1.91)秒对8.7(SD:0.6)秒[MD:3.2秒;(95%CI:2.63,3.76;P<0.001)];然而,差异在临床上不相关。首次尝试插入、血流动力学稳定性和术后并发症具有可比性(P>0.05)。

结论

与盲目插入相比,米勒喉镜引导可视下插入LMA Blockbuster可改善与会厌结构的对齐。

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