Comparing positive pressure ventilation efficacy of a novel foot operated resuscitator with self-inflating bag and mask in a manikin model

Aim To compare positive pressure ventilation efficacy of a novel foot operated resuscitator (FOR) during positive pressure ventilation with that of self-inflating bag and mask (SIBM) using a manikin model. Method A comparative trial was conducted with 117 participants at a level III neonatal intensive care unit using Baby Anne (Laerdal Medical, Norway). Flow and pressure sensors were used to measure tidal volume propelled (Vp) and delivered (Vt). Each participant delivered 60 breaths, using each device targeting adequate chest-rise defined as that corresponding to a Vt of 15–21 mL. Vt, Peak Inspiratory Pressure (PIP), Leak Percentage (%), Inspiratory Time (Ti, millisecond) and other parameters were recorded using a PC (Dell, Windows V.10) on a custom application (LabView 2014 platform NI, USA). The proportion of breaths achieving target range Vt, other key ventilation parameters and their variability were compared between a generic CE approved bag and mask and a novel FOR (NeoBreathe, Phoenix Medical Systems, India). Result Using an SIBM, participants delivered a mean (SD) Vt of 17.52 (5.22) mL, achieving target range Vt in 46.99% of all breaths, with a mean (SD) face-mask leak per cent of 32.51% (22.25). Using the FOR, participants delivered a mean (SD) Vt of 18.31 (3.90), achieving target range Vt in 54.37% of all breaths and a mean (SD) face-mask leak per cent of 18.89% (14.45). Variability of Vt, PIP and leak per cent was significantly reduced with FOR. Conclusion FOR significantly reduced face-mask leak, significantly increased the proportion of breaths achieving Vt within optimal range and could offer a novel alternative to a SIBM.