Flexible bronchoscopic intubation through the AuraGain? laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial

摘要

Abstract Purpose AuraGain TM , a novel third-generation laryngeal mask, can facilitate insertion of a gastric tube and provide the potential advantage of intubation. Data are lacking on intubation through the AuraGain laryngeal mask. Methods Eighty-eight hip or knee surgery patients were enrolled in this parallel randomized-controlled trial. We hypothesized that intubation time using the AuraGain laryngeal mask would be no longer than that for standard flexible bronchoscopic intubation over a slit Guedel tube, with a non-inferiority margin of five seconds. The following data were recorded during a maximum of three intubation attempts: intubation time, number of intubation attempts, degree of resistance to advance the endotracheal tube, and mask placement (i.e., Brimacombe score). Follow-up outcomes, including neck pain, hoarseness, and dysphagia, were also measured two and 24 hr postoperatively. Patients and outcome assessors remained blinded until the last examination. Results Mean intubation time was similar between the Guedel tube and AuraGain groups (23.6 sec vs 21.4 sec, respectively). The upper limit of the 95% confidence interval (CI) of the difference in mean intubation time between groups fell below our pre-specified non-inferiority margin; therefore, we found the AuraGain laryngeal mask to be non-inferior to the slit Guedel tube (adjusted group difference, ?1.6 sec; 95% CI, ?3.7 to 0.5). Successful intubation was achieved in the majority of patients (≥ 95%) in each group on the first attempt. No resistance to insertion of the endotracheal tube was encountered in the majority of patients in each group, and no complications were reported during the 24-hr postoperative period. There was no difference in the Brimacombe score or in the status of postoperative morbidity between the two groups. Conclusion We conclude that flexible bronchoscopic intubation through an AuraGain laryngeal mask can be achieved at least as fast as standard bronchoscopic intubation without contributing to additional patient morbidity or postoperative discomfort. Trial registration www.clinicaltrials.gov , NCT 02570269. Registered 23 September 2015.