Ventilating the Bearded: A Randomized Crossover Trial Comparing a Novel Bag-Valve-Guedel Adaptor to a Standard Mask

Abstract Introduction: Emergency field ventilation using bag-valve face mask devices can be difficult to perform, especially in bearded individuals. In view of the increasing numbers of servicemen and civilians sporting a beard or moustache, the issue of finding a technical solution for ventilation in this population has gained importance. We therefore developed a novel adaptor that enables the direct connection of a bag-valve device to a Guedel-type oropharyngeal airway device thereby directly connecting the oral airway to the bag valve, eliminating the need for a face mask. The objective of this study was to compare the efficacy of the bag-valve-Guedel adaptor (BVGA) to the common face mask in healthy bearded volunteers. Methods: This study was a randomized-by-sequence, crossover-controlled trial (NCT02768246) approved by the local IRB (0051-16-HMO). All subjects signed an informed consent before participation. Twenty-five healthy bearded men (age 28 ± 7) were recruited. After randomization, the first group (mask then BVGA, n = 12) began breathing room air through the face mask, followed by 100% O2. After washout in room air, the procedure was repeated with the BVGA. The second group (BVGA then mask, n = 13) began with the BVGA followed by the face mask. Subjects were awake and breathed spontaneously throughout the experiment. Therefore, a Guedel was not used. Physiological and respiratory parameters were monitored continuously. The primary endpoint was the presence of suspected leak as determined by end-tidal-CO2 (EtCO2 0.05 by Mann-Whitney-U test); therefore, the data were pooled. There were no cases of suspected leak while breathing through the BVGA. By contrast, while breathing through a face mask, there were 8 of 25 (32%) and 5 of 25 (20%) cases of suspected leak in air and 100% O2, respectively (air: p = 0.002; 100% O2: p = 0.014 by McNemar test). No adverse events were observed. Conclusions: In bearded individuals, the BVGA provides significantly more efficient (less leak) ventilation compared to a face mask. This is also of particular importance in view of the increasing number of bearded individuals serving in the armed forces. Moreover, since effective ventilation with a mask requires experience, the relatively easy-to-apply BVGA will enable less experienced first responders to achieve higher success r