Effectiveness and Safety of a Novel Approach for Management of Patients with Potential Difficult Mask Ventilation and Tracheal Intubation: A Multi-center Randomized Trial
Ji-Ming Wang1, Er-Li Ma1, Qing-Ping Wu2, Ming Tian3, Yan-Yan Sun4, Jing Lin1, Liang Peng1, Qiang Xu2, Wei Wei3, Hong Tan3, Cen Yang4, Xiao-Qiang Li1, Yun-Xia Zuo1, Jin Liu1
1 Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
2 Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430000, China
3 Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
4 Department of Anesthesiology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shaanxi 710000, China
Dr. Yun-Xia Zuo
Department of Anesthesiology and Translational Medical Neuroscience Center, West China Hospital, Sichuan University, Guoxuexiang 37#, Chengdu, Sichuan 610041
Source of Support: None, Conflict of Interest: None
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%, χ2 = 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%, χ2 = 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.
背景：困难气道处理不当可能危及患者生命安全，麻醉医生必需避免 “不能通气，不能插管” 危急现象的出现。因此，全身麻醉诱导前气道风险的评估甚为重要，尤其是那些存在潜在通气困难和插管困难的病人。然而，目前临床上还没有恰当的评估方法。本研究针对此类病人设计出一种快速困难气道评估方法（FDAE）即采用低浓度七氟烷吸入麻醉逐步加深镇静深度，观察评估通气困难程度，并据此决定全身麻醉诱导方法。本研究假设此方法能减少清醒插管。
方法：将302例准备全麻下行择期手术的潜在通气困难的高危患者随机分为七氟烷快速评估组（简称E组; 155例）与局部麻醉评估对照组（简称 C组; 147例）。前者采用低浓度七氟烷开始缓慢逐渐镇静，观察气道通畅程度的改变和评估通气难易程度。根据患者对镇静的耐受程度选择全身麻醉诱导或者清醒诱导。对照组采用1%丁卡因或2%利多卡因局麻下行声门暴露，根据声门暴露程度选择麻醉诱导和插管方法。观察主要指标是清醒插管率及诱导耗费时间，次要指标是两组患者麻醉诱导期间并发症，术后随访调查患者对麻醉诱导的满意度。
结果：清醒插管率E组明显低于C组 (5.81% vs. 36.05%, χ2 = 42.3, P <0.001)。诱导时间E组明显短于C组，两组诱导及插管的并发症没有统计学意义。 E组术后随访病人对诱导评估的记忆低于C组患者(9.68% vs. 44.90%, χ2 = 47.68, P <0.001)，E组满意度评分高于C组患者( t = 15.36, P <0.001)。