Perioperative respiratory adverse events in children undergoing adenotonsillectomy with laryngeal mask airway versus endotracheal tube ventilation: multicentre, randomised controlled trial

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 NCT2300071399 .