Abstract: Objective: The aim of this study is to analyze the safety of a large number cases of percutaneous dilatation tracheostomy.Method: Retrospective analyzed the clinical data of PDT (1 200 cases) and TT (326 cases) patients which were recruited. The postoperative complications were analyzed statistically. PDT and TT randomized controlled trials (PDT and TT) were conducted with 80 cases in each group. The intraoperative conditions (including operative time, intraoperative bleeding volume and incision size) and postoperative complications in the two groups were statistically analyzed. The data were analyzed by SPSS 17.0 software.Result: ①Randomized controlled study:The blood loss, incision size and operative time of two groups have significant difference. Comparison of postoperative complications:the number of postoperative bleeding and the total number of complications were statistically significant difference (P<0.05). However, granulation formation, incision infection and subcutaneous emphysema showed no significant difference (P>0.05). ②Large sample study:The postoperative follow-up results showed that there were significant differences in postoperative bleeding, postoperative infection, subcutaneous emphysema and the total number of complications (P<0.05), but there was no significant difference in the formation of tracheal granulation (P>0.05).Conclusion: This study further validates that PDT is a safe method to establish long-term artificial airway through large sample and randomized controlled study, which accords with the direction of modern minimally invasive surgery. PDT not only short operation time, and is easy to grasp, but also safe and reliable. If there is no obvious operation contraindication, we can choose PDT first for critically ill patients who need tracheotomy, and the success rate and safety are high after mastering the operation skills.