Abstract
BACKGROUND: Fibreoptic bronchoscope (FOB) is considered complex to learn and operate, and it remains controversial whether videolaryngoscopy can be used as an alternative to FOB for awake tracheal intubation (ATI). AIMS: The Objective is to compare the effectiveness of Safe Easy Endotracheal kit-flexible (SEEK(flex))/video laryngoscopy and FOB in ATI. METHODS: We conducted a pragmatic, multicentre, non-blinded, randomized, parallel-group clinical trial in Shanghai and Putian, China. Between January 2023 and June 2024, patients aged 18-80 years who required ATI and were able to adapt to videolaryngoscopy were enrolled. We randomly assigned 148 patients who received ATI to two groups in a 1:1 ratio: SEEK(flex)/videolaryngoscopy group and FOB group. The rate of successful intubation at the first attempt was the primary outcome. Secondary endpoints were time to tracheal intubation; patient-reported satisfaction with the technique; and complications arising from intubation. RESULTS: Successful intubation at the first attempt was achieved in 69 cases (93%) using SEEK(flex) /videolaryngoscopy and only 58 cases (80%) using FOB, p = 0.015. The median (IQR [range]) time to tracheal intubation was 59 (51-66 [29-150]) s in the SEEK(flex)/videolaryngoscopy group and 92 (77-157 [40-869]) s in the FOB group, p < 0.001. The median (IQR [range]) scores for patient satisfaction were 8 (7-9 [4-10]) and 6 (4-7 [1-10]) in the SEEK(flex)/videolaryngoscopy group and the FOB group, respectively, p < 0.001. SEEK(flex)/videolaryngoscopy attenuated the incidence of postintubation complications. CONCLUSIONS: SEEK(flex)/videolaryngoscopy can be used as an alternative to FOB in clinical practice when ATI is required due to the high rate of successful intubation at the first attempt, short intubation time, low complication rate and high patient satisfaction scores. TRIAL REGISTRATION: ChiCTR2300067555, 01/11/2023.