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喉罩气道 Supreme 与喷射管气管插管在麻醉成年患者中的比较:一项随机对照试验。

Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial.

机构信息

From the Department of Anaesthesiology and Intensive Care, San Bortolo Hospital, Vicenza (SDR, AR, AP, EB, PG, VU, AP, RB, SCC), Department of Anaesthesia and Intensive Care Medicine, Maggiore Della Carità University Hospital, Novara (AM, DC) and Anesthesia and Intensive Care, AOU Policlinico Vittorio Emanuele, Catania, Italy (MS).

出版信息

Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106.

Abstract

BACKGROUND

The Spritztube is a new supraglottic airway device combining the ability to allow extraglottic ventilation of the lungs with the opportunity to perform fibreoptic-assisted intubation.

OBJECTIVES

To compare the Spritztube tracheal cannula with the Laryngeal Mask Airway Supreme (LMA-S) in anaesthetised adult patients.

DESIGN

A single-centre, randomised controlled study.

SETTING

Tertiary hospital.

PATIENTS

Mechanically ventilated patients undergoing elective surgery in the supine position under general anaesthesia were included. Main exclusion criteria were a history of, or predicted, difficult airway management according to SIAARTI guidelines and absence of written informed consent.

INTERVENTIONS

Patients received the LMA-S or Spritztube tracheal cannula to facilitate ventilation of the lungs.

MAIN OUTCOME MEASURES

Successful placement (primary outcome), time required for insertion, number of attempts, subjective assessment of ease of insertion, safety and incidence of complications were recorded.

RESULTS

One hundred and sixty seven patients were allocated to the LMA-S or Spritztube group, respectively, a total of 334 patients. In the LMA-S group, the device insertion failed in nine patients, compared with none in the Spritztube group (P = 0.002). Spritztube insertion was easy in 100% of cases compared with 94.6% of the cases in the LMA-S group (P = 0.03). The number of attempts was significantly higher with the LMA-S compared with the Spritztube (P = 0.0007), whereas the insertion times were comparable (P = 0.06). Except for the incidence of blood-staining, which was higher in the LMA-S group (P = 0.01), the number of complications was comparable in the two groups.

CONCLUSION

The Spritztube was as effective as the LMA-S in maintaining the airway with all patients being successfully ventilated without difficulty. The success rate of achieving a patent airway was comparable between the groups, with a similar occurrence of complications.

TRIAL REGISTRATION

NCT03443219.

摘要

背景

Spritztube 是一种新型的声门上气道装置,结合了允许肺部进行声门外通气的能力,以及进行纤维光辅助插管的机会。

目的

比较 Spritztube 气管插管与喉罩气道 Supreme(LMA-Supreme)在麻醉成年患者中的效果。

设计

单中心、随机对照研究。

地点

三级医院。

患者

纳入在全身麻醉下仰卧位接受择期手术且需要机械通气的患者。主要排除标准为根据 SIAARTI 指南预测有困难气道管理史或困难气道管理预测值以及无书面知情同意书。

干预措施

患者接受 LMA-S 或 Spritztube 气管插管以辅助肺部通气。

主要观察指标

成功放置(主要结局)、插入所需时间、尝试次数、插入的主观评估、安全性和并发症发生率。

结果

167 例患者分别被分配到 LMA-S 或 Spritztube 组,共 334 例患者。在 LMA-S 组中,9 例患者装置插入失败,而 Spritztube 组无一例失败(P=0.002)。Spritztube 插入在 100%的病例中被认为很容易,而在 LMA-S 组中这一比例为 94.6%(P=0.03)。LMA-S 的尝试次数明显高于 Spritztube(P=0.0007),而插入时间相当(P=0.06)。除 LMA-S 组出血发生率较高(P=0.01)外,两组的并发症数量相当。

结论

Spritztube 与 LMA-S 一样有效,所有患者均能成功通气,无需困难地维持气道。两组的气道通畅成功率相当,并发症发生率相似。

试验注册

NCT03443219。

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