Use of a novel pedal‐operated compressor is non‐inferior to the use of a standard hand‐compressed bag‐valve mask

Background The standard bag‐valve mask (BVM) used universally requires that a single healthcare practitioner affix the mask to the face with 1 hand while compressing a self‐inflating bag with the second hand. Studies have demonstrated that creating a 2‐handed seal (with 2 healthcare practitioners) is superior. Our study aims to assess the efficacy of a novel single‐practitioner BVM device that uses a foot pedal as the bag compressor, allowing both hands to be available for the seal to facilitate delivery of appropriate tidal volumes during single‐practitioner resuscitation. Methods This was a prospective, randomized, cross‐over study. Participants with various BVM ventilation experience performed 2 minutes of metronome‐guided BVM ventilation using a standard BVM and the pedal‐operated compressor on a high‐fidelity simulation mannequin. Analysis examining differences in mean tidal volume delivered was conducted using a regression model that adjusted for covariates. A secondary analysis using a series of Wilcoxon tests was conducted to compare differences in the additional out‐of‐range sensed breaths metrics to compare differences by prior BVM ventilation experience. Results A total of 58 subjects participated. The pedal‐operated compressor unadjusted mean tidal volume delivered was 446.5 mL (95% confidence interval [CI], 425.9–467.1) compared with 340.6 mL (95% CI, 312.2–369.0) by standard BVM (mean change, 105.9 mL [95% CI, 71.2–140.6]; P