Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Department of Medical Statistics, Daegu Catholic University College of Medicine, Daegu, Republic of Korea.
PLoS One. 2018 Oct 4;13(10):e0204846. doi: 10.1371/journal.pone.0204846. eCollection 2018.
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.
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.
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.
The tube lubricated with water did not reduce sore throat and pharyngeal injury after tracheal intubation compared to the tube without lubrication.
气管插管后常发生咽喉痛。可使用水来润滑气管导管,但尚未证实其益处。因此,我们进行了一项随机非劣效性试验,以检验水润滑的导管不会减少气管插管后咽喉痛的假设。
我们将接受耳部或眼部手术的女性或男性患者(n=296)随机分为水润滑组或非润滑组进行插管。我们在术后 0、2、4 和 24 小时评估咽喉痛;术后 2 和 24 小时评估咽部损伤;术后 7 天内评估呼吸道感染。对于术后 24 小时内咽喉痛的发生率(主要结局),我们比较了风险差异的双侧 90%置信区间与预设的非劣效性边界 15%。其他结局采用双侧优势检验进行分析。
术后 24 小时内咽喉痛的发生率在非润滑组为 147/147(80.3%),在水润滑组为 149/149(86.6%)(风险差 -1.3%,90%置信区间 -10.9%至 8.3%)。由于置信区间低于非劣效性边界,非润滑组的咽喉痛发生率并不高于水润滑组。在每个评估时间点,两组之间的咽喉痛、咽部损伤和呼吸道感染均无显著关联。
与非润滑组相比,水润滑的导管并不能减少气管插管后的咽喉痛和咽部损伤。