Perioperative respiratory adverse events in children undergoing adenotonsillectomy with laryngeal mask airway versus endotracheal tube ventilation: multicentre, randomised controlled trial
Yuan Han, Xiuwen Yi, Junming Xia, Wei Zhang, Zengxiao Zhao, Nana Zhu, Ningning Liu, Xuejie Chen, Yingjie Wang, Lili Feng, Wenwen Ni, Yan Zhuang, Yaojing Fu, Fangyuan Qiu, Peipei Lv, Ji’e Jia, Yilei Shen, Yirong Cai, Xiangyi Kong, Weidong Hu, Zhendong Yang, Huiyan Hou, Jijian Zheng, Yingying Ji, Jing Wang, Thomas Heidegger, Yingping Jia, Wenxian LiAbstract
Objective
To assess the effect of ventilation with a laryngeal mask airway (LMA) compared with endotracheal tube (ETT) on perioperative respiratory adverse events (PRAEs) in children undergoing adenotonsillectomy.
Design
Multicentre, randomised, parallel group trial.
Setting
Four tertiary hospitals in China, 2023-24.
Participants
400 children aged ≥2 years and <7 years who were scheduled for adenotonsillectomy under general anaesthesia.
Interventions
Participants were randomised 1:1 to receive ventilation with a laryngeal mask airway (n=200) or an endotracheal tube (n=200) during adenotonsillectomy.
Main outcome measure
The primary outcome was the proportion of participants who developed any perioperative respiratory adverse event (PRAE): laryngospasm, bronchospasm, desaturation, airway obstruction, severe cough, or stridor in the intention-to-treat population.
Results
400 children (mean age 4.7 (standard deviation 1.0) years; 155 (38.7%) girls) were enrolled between 24 May 2023 and 4 April 2024, with last follow-up on 4 May 2024. LMA was converted to ETT in three participants. Overall, 22.5% (45/200) participants in the LMA group experienced PRAEs versus 57.5% (115/200) in the ETT group (absolute risk difference -35.0 percentage points, 95% confidence interval -43.5 to -25.7; P<0.001). The LMA group had fewer PRAEs in both the intraoperative (9.0% (18/200) v 17.5% (35/200); -8.5, -15.2 to -1.8; P=0.01) and the postoperative period (16.5% (33/200) v 49.5% (99/200); -33.0, -41.2 to -24.0; P<0.001). The LMA group also had a lower proportion of participants with laryngospasm (0.0% v 3.0%; P=0.03), desaturation (15.0% v 28.0%; P=0.002), airway obstruction (3.5% v 12.5%; P<0.001), and severe cough (10.5% v 42.0%; P<0.001). Neither group experienced serious adverse events.
Conclusion
Ventilation with an LMA by experienced anaesthesiologists resulted in fewer perioperative respiratory adverse events than ventilation with an ETT in children undergoing adenotonsillectomy.
Trial registration
Chictr.org.cn