Safety and Effectiveness of a Novel Facemask for Positive Pressure Ventilation.

BACKGROUND: Manual positive pressure ventilation is an essential skill in a variety of clinical situations. The C&E technique is commonly used with standard facemasks to provide effective ventilation. The Tao mask is a novel design that allows a more ergonomic grip. A seal between the mask and face is made with downward pressure of the palm, centered on the mask, and jaw lift is achieved with 4 fingers centered under the mandible. The purpose of this study was to evaluate the safety and effectiveness of the Tao mask compared to a standard mask before and after the administration of neuromuscular blockade (NMB) using 2 previously established ventilation scales.

METHODS: One hundred fifty-two patients >18 years of age who were scheduled for general anesthesia were recruited. All care team members were shown a brief instructional video on the use of the Tao mask. After induction of general anesthesia with a standardized protocol, each patient was ventilated with both the standard (Vital Signs #082510) and Tao masks and effectiveness was measured using the Han and Warters scales. This process was repeated after NMB. The sequence of masks was determined with a random-number generator.

RESULTS: Tao mask ventilation scores were significantly better than standard mask scores on both the Han scale and the Warters scale before the administration of NMB (P < .001 for both). Tao mask scores were also significantly better than standard mask scores on the Warters scale after the administration of NMB (P < .001). However, there was no significant difference on the Han scale between the 2 mask types after NMB (P = .180). On the Warters scale, there were significantly fewer patients who were difficult to ventilate with the Tao mask than the standard mask before NMB (18 vs 40; P < .001) and after NMB (8 vs 17; P = .005). No adverse events were reported with either mask.

CONCLUSIONS: Our results indicate that the Tao mask demonstrated equivalent safety and superior effectiveness compared to a standard mask. The study design favored the standard mask because all participating practitioners had multiple years of experience with the standard mask and no prior experience with the Tao mask. Since the incidence of inadequate mask ventilation goes up significantly with inexperienced operators, the improved effectiveness of the Tao mask could be even more profound with novice operators.