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一种新方法管理潜在困难面罩通气和气管插管患者的效果和安全性:一项多中心随机试验。

Effectiveness and Safety of a Novel Approach for Management of Patients with Potential Difficult Mask Ventilation and Tracheal Intubation: A Multi-center Randomized Trial.

机构信息

Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China.

Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430000, China.

出版信息

Chin Med J (Engl). 2018 Mar 20;131(6):631-637. doi: 10.4103/0366-6999.226897.

DOI:10.4103/0366-6999.226897
PMID:29521283
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5865306/
Abstract

BACKGROUND

: Patients with potential difficult mask ventilation (DV) and difficult intubation (DI) are often managed with awake intubation, which can be stressful for patients and anesthesiologists. This prospective randomized study evaluated a new approach, fast difficult airway evaluation (FDAE). We hypothesized that the FDAE approach would reduce the need for awake intubation.

METHODS

: After obtaining informed consent, 302 patients with potential DV/DI undergoing elective surgeries were randomly assigned to the FDAE group (Group E) and the control group (Group C). In Group E, patients were gradually sedated, and adequacy of manual mask ventilation during spontaneous breathing was assessed at various sedation levels. Awake intubation was applied in those with inadequate mask ventilation. In Group C, DI was evaluated under local anesthesia. However, the care team could intubate under general anesthesia if the vocal cords were visible. The primary outcome was the rate of awake intubations in both groups and the induction efficiency assessed by the induction time. The secondary outcome was the incidence of serious complications.

RESULTS

The rate of awake intubation was significantly lower in Group E than that in Group C (5.81% vs. 36.05%, χ = 42.3, P < 0.001). The induction time was much shorter in Group E than in Group C (11.85 ± 4.82 min vs. 18.71 ± 7.85 min, t = 5.39, P < 0.001). There was no significant difference in the incidence of intubation related complications between the two groups. Patients in Group E had a much lower incidence of recall (9.68% vs. 44.90%, χ = 47.68, P < 0.001) of the induction process and higher satisfaction levels than patients in Group C (t = 15.36, P < 0.001).

CONCLUSIONS

The FDAE significantly reduces the need for awake intubation and improves the efficiency of the intubation process without comprising safety in patients with potential difficult mask ventilation and DI.

TRIAL REGISTRATION

: No. ChiCTR-TRC-11001418; http://www.gctr.org/cn/proj/show.aspx?proj=1562.

摘要

背景

具有潜在困难面罩通气(DV)和困难插管(DI)的患者通常采用清醒插管进行管理,这可能会给患者和麻醉师带来压力。本前瞻性随机研究评估了一种新方法,即快速困难气道评估(FDAE)。我们假设 FDAE 方法将减少清醒插管的需求。

方法

在获得知情同意后,302 名具有潜在 DV/DI 并接受择期手术的患者被随机分配到 FDAE 组(E 组)和对照组(C 组)。在 E 组中,患者逐渐镇静,并在不同镇静水平下评估自主呼吸时手动面罩通气的充分性。如果面罩通气不足,则进行清醒插管。在 C 组中,在局部麻醉下评估 DI。但是,如果声带可见,医护团队可以在全身麻醉下插管。主要结局是两组清醒插管的发生率和以诱导时间评估的诱导效率。次要结局是严重并发症的发生率。

结果

E 组清醒插管的发生率明显低于 C 组(5.81%比 36.05%,χ=42.3,P<0.001)。E 组的诱导时间明显短于 C 组(11.85±4.82min 比 18.71±7.85min,t=5.39,P<0.001)。两组插管相关并发症的发生率无显著差异。E 组患者的回忆发生率(9.68%比 44.90%,χ=47.68,P<0.001)明显低于 C 组,且满意度水平明显高于 C 组(t=15.36,P<0.001)。

结论

在具有潜在困难面罩通气和 DI 的患者中,FDAE 显著降低了清醒插管的需求,提高了插管过程的效率,同时不影响安全性。

试验注册

无。ChiCTR-TRC-11001418;http://www.gctr.org/cn/proj/show.aspx?proj=1562。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/763f10a4824a/CMJ-131-631-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/f7ab510b7c90/CMJ-131-631-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/61d5c1e07fea/CMJ-131-631-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/763f10a4824a/CMJ-131-631-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/f7ab510b7c90/CMJ-131-631-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/61d5c1e07fea/CMJ-131-631-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/5865306/763f10a4824a/CMJ-131-631-g003.jpg

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