Time to tracheal intubation over a fibreoptic bronchoscope using a silicone left double-lumen endobronchial tube versus polyvinyl chloride single-lumen tube with bronchial blocker: a randomized controlled non-inferiority trial

摘要

Background: Direct insertion of a double-lumen endobronchial tube (DLT) over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube (SLT). We hypothesized that time to intubation over an FOB using a silicone left DLT would be non-inferior to that using a polyvinyl chloride (PVC) SLT. Methods: Eighty patients were enrolled in this open-label, randomized controlled, non-inferiority trial. Patients were randomly allocated to fibreoptic tracheal intubation with either a silicone DLT or PVC SLT (DLT and SLT groups, respectively). Time to tracheal intubation [time to insertion of FOB plus railroading (advancement over the FOB) time]; total time for correct tube and bronchial blocker positioning; difficulty of railroading; and the incidence of sore throat, swallowing difficulty, and hoarseness were compared between groups. Results: The median time to intubation over the FOB was 20 s in the DLT group and 23 s in the SLT group. The upper limit of the confidence interval of this difference was below the non-inferiority margin of 10 s (median difference: –2 s; 95% confidence interval: –4 to 0 s). Railroading time was significantly shorter in the DLT group than in the SLT group (median time: 10 vs . 11 s; median difference: –1 s; 95% confidence interval: –3 to 0 s; P=0.03). Railroading over the FOB (rated on a four-point scale) was less difficult in the DLT group than in the SLT group (P Conclusions: Tracheal intubation using an FOB can be achieved at least as fast using the silicone DLT as using the PVC SLT. The silicone DLT exhibited superior railroading performance to the PVC SLT.