Tracheal tubes lubricated with water to reduce sore throat after intubation: A randomized non-inferiority trial.

BACKGROUND: Sore throat is common after tracheal intubation. Water can be used to lubricate tracheal tubes, but its benefit has not been validated. We thus did a randomised non-inferiority trial to test the hypothesis that a tube lubricated with water does not reduce sore throat after tracheal intubation. METHODS: We randomized female or male patients (n = 296) undergoing surgery in the ears or eyes to receive either a tube lubricated with water or a tube without lubrication for intubation. We assessed sore throat at 0, 2, 4, and 24 h after surgery; pharyngeal injury at 2 and 24 h after surgery; and respiratory infections within 7 days after surgery. For the incidence of sore throat within 24 h after surgery (primary outcome), the two-sided 90% confidence interval of the risk difference was compared with the prespecified non-inferiority margin of 15%. Other outcomes were analyzed with two-sided superiority tests. RESULTS: The incidence of sore throat within 24 h after surgery was 80/147 (54.4%) in the non-lubricated tube group and 83/149 (55.7%) in the water-lubricated tube group (risk difference -1.3%, 90% confidence interval -10.9% to 8.3%). Because the confidence interval was below the non-inferiority margin, the incidence of sore throat was not higher in the non-lubricated tube group than in the water-lubricated tube group. There was no significant association between groups in the sore throat, pharyngeal injury, and respiratory infection at each assessment time. CONCLUSIONS: The tube lubricated with water did not reduce sore throat and pharyngeal injury after tracheal intubation compared to the tube without lubrication.