Pre-intubation ventilation device for bearded patients: prospective, randomized, crossover trial in anesthetized patients.

Having a beard is an independent predictor of difficult ventilation by face mask. This study evaluates the efficacy of a novel intra-oral Bag-Valve-Guedel Adaptor (BVGA) in anaesthetized bearded patients. Patients with ASA score 1-2, scheduled for elective surgery, were recruited for this prospective, crossover trial. Beard length was categorized as < 0.5 cm, 0.5-1 cm, 1-5 cm, or > 5 cm. Patients were ventilated by attending anesthesiologists using the BVGA and a facemask (both with a Guedel oral airway). End-tidal CO 2 (EtCO 2 ) and expiratory tidal volume (TV) were recorded as was the number of hands required for the procedure. The primary outcome was the difference between BVGA and Facemask. Sixty-one patients were enrolled. Of these, 38 had beards, and 23 were without beards or with beards < 0.5 cm length. In bearded patients, ventilation with the BVGA was superior to the face mask by EtCO 2 and non-inferior by TV (BVGA-vs-Mask, mean [95% CI]: EtCO 2 [mmHg], 33.0 [31.6, 34.3]-vs-27.2 [25.5, 28.8], p < 0.001; TV [ml∙kg -1 IBW], 8.1 [7.4, 8.9]-vs-6.9 [6.0, 7.7], p = 0.11). The BVGA was found to be superior to the face mask by EtCO 2 across all beard lengths (p ≤ 0.001), but by TV only for the longest beard group (p = 0.009). After securing the BVGA, ventilation was possible without hands in 74% of the cases - clearly impossible with the facemask (p ≤ 0.001). The BVGA is more effective and more convenient than the facemask in anaesthetized bearded patients. A follow-up study is underway to test whether replacing the face mask with the BVGA will improve effectiveness and ease of pre-intubation field ventilation by less-experienced, first responders.