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在接受脑动脉瘤栓塞术的患者中,比较 Jcerity 内镜气道与 LMA supreme 用于气道管理的效果:一项随机对照非劣效性试验。

Comparison of the Jcerity Endoscoper Airway with the LMA supreme for airway management in patients undergoing cerebral aneurysm embolization: a randomized controlled non-inferiority trial.

机构信息

Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.

Department of Pain Medicine, the Second Affiliated Hospital of Zhengzhou University, Zhengzhou, China.

出版信息

BMC Anesthesiol. 2022 Apr 26;22(1):121. doi: 10.1186/s12871-022-01666-w.

Abstract

BACKGROUND

Jcerity Endoscoper Airway is a new back-open endoscopic laryngeal mask airway device with a unique design. Our study sought to compare the implantation, ventilation quality and complications of JEA (Jcerity Endoscoper airway) versus LMA (Laryngeal Mask Airway) Supreme in the procedure of cerebral aneurysm embolization.

METHODS

In this prospective, randomised clinical trial, 182 adult patients with American Society of Anesthesiologists class Ι-II scheduled for interventional embolization of cerebral aneurysms were randomly allocated into the Jcerity Endoscoper airway group and the LMA Supreme group. We compared success rate of LMA implantation, ventilation quality, airway sealing pressure, peak airway pressure, degree of blood staining, postoperative oral hemorrhage, sore throat and other complications between the groups.

RESULTS

There were no significant differences between the groups in terms of one-time success rate of LMA implantation, ventilation quality, airway sealing pressure or airway peak pressure. However, LMA Supreme group showed a higher degree of blood staining than the JEA group when the laryngeal mask airway was removed (P = 0.04), and there were also more oral hemorrhages and pharyngeal pain than JEA group (P = 0.03, P = 0.02). No differences were observed between groups in terms of other airway complications related to the LMA.

CONCLUSIONS

The JEA could not only achieve comparable one-time success rate of implantation and quality of ventilation as the LMA Supreme, but also have lower blood staining degree of mask and less sore throat in patients undergoing perioperative anticoagulation for cerebral aneurysm interventional embolization.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR2100044133 ; Registered 11/03/2021. Statement: This study adheres to CONSORT guidelines.

摘要

背景

Jcerity 内镜型气道是一种具有独特设计的新型后开式内镜喉罩气道装置。我们的研究旨在比较 JEA(Jcerity 内镜型气道)与 LMA Supreme(喉罩气道)在脑动脉瘤栓塞介入治疗过程中的植入、通气质量和并发症。

方法

在这项前瞻性、随机临床试验中,182 名美国麻醉医师学会(ASA)Ⅰ-Ⅱ级的成年患者被随机分配到 Jcerity 内镜型气道组和 LMA Supreme 组,进行脑动脉瘤的介入栓塞。我们比较了两组患者的喉罩一次植入成功率、通气质量、气道密封压、气道峰压、血迹程度、术后口腔出血、咽痛等并发症。

结果

两组患者喉罩一次植入成功率、通气质量、气道密封压或气道峰压均无显著差异。然而,当喉罩气道被取出时,LMA Supreme 组的血迹程度明显高于 JEA 组(P=0.04),且口腔出血和咽部疼痛的发生率也明显高于 JEA 组(P=0.03,P=0.02)。两组患者在与 LMA 相关的其他气道并发症方面无差异。

结论

JEA 不仅可以达到与 LMA Supreme 相当的一次性植入成功率和通气质量,而且在接受脑动脉瘤介入栓塞围手术期抗凝治疗的患者中,其气道的血迹程度较低,咽痛较轻。

试验注册

中国临床试验注册中心,ChiCTR2100044133;注册日期:2021 年 11 月 3 日。声明:本研究符合 CONSORT 指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/100c/9040346/e38b683cf85d/12871_2022_1666_Fig1_HTML.jpg

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