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 < .001). When modeling a generalized estimation equation regression model, standard BVM ventilation provided a mean difference of 105.9 mL less than pedal-operated compressor ventilation after adjusting for covariates (P = 0.01). For the secondary outcome, the pedal-operated compressor did have a significantly lower median number of out-of-range breaths (median, 3; interquartile range [IQR], 1-11.5) compared with the standard device (median, 13.5; IQR, 6-19; P < 0.001). Conclusions Use of a novel pedal-operated compressor may allow a single healthcare practitioner, regardless of prior experience, to deliver consistent, appropriate tidal volumes with more ease compared with the standard BVM during manual respiratory resuscitation.