一次性气管插管用引导管芯在困难气管插管中的临床应用研究

A study on the clinical application of disposable guided stylets in difficult tracheal intubation

目的评价实用新型专利产品一次性气管插管用引导管芯在困难气管插管中的临床应用效果。方法49例预测为困难气管插管患者（CormackandLehane分级为Ⅲ级或Ⅳ级）随机分为两组。I组（对照组，n=34）使用临床上常用的经口气管导管加用普通管芯经口插管；Ⅱ组（实验组，n=41）：15例和I组中两次插管不成功26例，共41例使用一次性气管插管用引导管芯引导插管。记录两组插管时间、并发症、成功率以及一次性气管插管用引导管芯自带的管芯位置检测功能的准确率等。结果Ⅱ组的首次插管和两次插管总成功率（65．85％，92．68％）分别高于I组（5．88％，23．5％），差异有统计学意义（P〈0．01）。Ⅱ组的成功插管平均时间[（175．00±44．60）s]少于I组[（321．66±78．84）s]，差异有统计学意义（P〈0．01）。Ⅱ组的插管即时出血和心动过速等并发症发生率（19．5％）小于I组（76．5％），差异有统计学意义（P〈0．01）。产品自带的管芯位置检测功能检测导管位置的敏感性、特异性和准确率分别为86．1％（95％CI，74．8％-97．4％）、63．1％（95％CI，41．4％～84．8％）和78．2％（95％CI，67．2％-89．1％）。结论针对预测为困难气管插管患者，实用新型专利产品一次性气管插管用引导管芯引导插管与使用传统管芯的经口气管插管比较有较高的成功率和安全性，其自带的管芯位置检测功能有一定可靠性，可以作为呼吸末二氧化碳监测仪或临床听诊法等确认导管位置方法的补充。

Objective To assess the clinical application of disposable guided stylets in difficult tracheal intubation. Methods Forty-nine patients with Cormack-Lehane grades III or IV who were likely to suffer with difficult tracheal intubation were divided into two groups. Patients in Group I （n=34） underwent routine tracheal intubation with a common guided stylet. In contrast, Group II （n=41） included 15 patients and those from Group I （n=26） who failed to undergo routine tracheal intubation. These patients underwent tracheal intubation using a new disposable guided stylet. Then, the duration of intubation of both groups, complications, the success rate and the accuracy of a disposable guided stylet to determine position were recorded. Result The first success rate and the twice success rate in Group II （65.85% and 92.68%, respectively） were significantly higher than those in Group I （5.88% and 23.5%; all p〈0.01）. The mean time of successful intubation in Group II （175.00±44.60s） was remarkably shorter than that in Group I （321.66± 78.84s, P 〈0.01）.Group II resulted in less complications like immediate bleeding and tachycardia （19.5%） than Group I （76.5% ,P 〈0.01）. The stylet had 86.1% of sensitivity （95% CI, 74.8%-97.4% ）, 63.1% of specificity （95% CI, 41.4%-84.8%）, and 78.2% of accuracy （95% CI, 67.2%-89.1%） when used to detect position Conclusion As a patented product with novel use, the disposable guided stylet is superior over routine stylet, with a better success rate of intubation and improved safety when applied in patients who are likely to suffer with difficult tracheal intubation. In addition, the stylet can detect position which can be a supplementary approach for ETCO（2） monitoring and clinical diagnosis.