Randomized controlled trial assessing intubation time with and without an aerosol biocontainment device

Abstract

Introduction: The emergence of the coronavirus disease 2019 (COVID-19) pandemic renewed interest in infectious aerosols and methods to reduce risk of airborne respiratory pathogen transmission. This has led to the development of novel aerosol protective devices for which clinical and aerosol protective features have not been fully characterized. The relative efficacy of these devices for use during airway procedures has not been assessed in randomized controlled trials. Materials and Methods: We recruited anesthesiology attendings, residents, and certified registered nurse anesthetists to perform intubations with an aerosol biocontainment device (ABCD). Thirty-seven patients undergoing procedures requiring intubation in the operating room were recruited and randomized (2:1) to intubation with (25) or without (12) the ABCD. Primary endpoints were time to secure the airway and adverse events. Secondary endpoints were a number of intubation attempts, access to the patient and airway equipment through the device ports, user assessment of ABCD function and technical burden, and patient experience in the ABCD. Results: Intubation time with the ABCD (46 s) was not significantly different compared to intubation without the ABCD (37 s; P=0.06). There were 3 adverse events with the ABCD (1 claustrophobia, 2 unanticipated difficult airways) that required device removal for intubation. In general, patients tolerated the device well and ABCD users felt the device functioned as intended but increased the technical burden associated with intubation. Discussion: It is feasible to use an aerosol protective device for intubation. The introduction of novel devices into high acuity airway procedures should be approached with caution and should account for the risk mitigation gained from the device balanced against the increased procedural complexity and potential safety risks associated with restricted access to the airway.