AuraGain™ versus i‐gel™ for bronchoscopic intubation under continuous oxygenation: A randomised controlled trial

Abstract

Introduction After failed mask ventilation and tracheal intubation, guidelines issued by the Difficult Airway Society recommend placing a second generation supraglottic airway device to secure oxygenation. Ultimately, a secure airway can be obtained by tracheal intubation through the supraglottic airway device using a bronchoscope. In this randomised trial, we compared the AuraGain™ with the i‐gel™ as conduit for bronchoscopic intubation under continuous oxygenation performed by a group of anaesthesiologists with variable experience in a general population of patients. Method We randomised one hundred patients who were equally allocated to flexible bronchoscopic intubation through the i‐gel™ or the AuraGain™. In a random order, 25 anaesthesiologists each performed four intubations, two using the i‐gel™ and two using the AuraGain™. Our primary outcome was ‘total time for airway management’; i.e. total time from manually reaching the SAD to successful FBI confirmed at the end of the first inspiratory downstroke on the capnography curve. Results In total, 87% (95% CI, 79%–92%) of the patients were successfully intubated through the allocated supraglottic airway device. There was no difference in total time for airway management between the i‐gel™ and the AuraGain™ (199 vs. 227 s, p = .076). However, there was a difference in time for placement of the i‐gel™, compared to the AuraGain™, (37 vs. 54 s, p < .001). There were nine failed intubations in the AuraGain™ group compared to four in the i‐gel™ group (p = .147). Conclusion We found no difference in total time for airway management between using the i‐gel™ and using the AuraGain™.

Flexible bronchoscopic intubation through a supraglottic airway device: An evaluation of consultant anaesthetist performance

“…The study was a pre-planned observational sub-study (clinicaltrials.gov identifier NCT04743440) of an RCT that compared two different SADs as conduit for FBI (clinicaltrials.gov identifier: NCT04680169). 9 The study was approved by the Ethics Committee (H-20016428) and unit for data security (P-2020-440), Capital Region of Denmark. Trial data was collected at New North Zealand Hospital (regional hospital with the following surgical specialties: ear-nose-throat, gynaecology and obstetrics, gastroenterology, and orthopaedics) from 18th of January 2021 to 4th of May 2021.…”

“…The study was a pre‐planned observational sub‐study (http://clinicaltrials.gov identifier NCT04743440) of an RCT that compared two different SADs as conduit for FBI (http://clinicaltrials.gov identifier: NCT04680169) 9 . The study was approved by the Ethics Committee (H‐20016428) and unit for data security (P‐2020‐440), Capital Region of Denmark.…”

“…A thorough description of the patient population is published. 9 For this study, we obtained the following patient data; sex, age, and Simplified Airway Risk Index (SARI) score. 12…”

“…[3][4][5][6][7][8] Conversely, optimal view of the vocal cords has only been reported in 60%-78% of patients using FBI through a SAD. 3,5,8 During our planning of a randomised controlled trial (RCT), 9 which compared two SADs (Ambu AuraGain™ [AA] vs.…”

“…Conversely, optimal view of the vocal cords has only been reported in 60%–78% of patients using FBI through a SAD 3,5,8 . During our planning of a randomised controlled trial (RCT), 9 which compared two SADs (Ambu AuraGain™ [AA] vs. Intersurgical i‐gel™ [IG]) as conduit for FBI under continuous ventilation, we identified 20 procedural steps in order to properly secure the airway. We questioned the ease of the procedure, especially in a true difficult airway situation where patients may delineate fast, and human factors may play a role 10 .…”