Manual Bag Valve Mask Ventilation Performance With Safety Device Among Second Year Respiratory Therapy Students: A Non-Inferiority Trial Design Study

Abstract

Background:

Resuscitator bags are common in acute care settings; however, poor technique is a well-documented problem which occurs irrespective of a provider’s qualifications or experience. A safety device has been created (Sotair) to improve the quality of air delivery via resuscitation bags by preventing harmful effects of manual ventilation. This study seeks to determine the differences in airflow measurements between the Sotair device via bag-valve mask and the mechanical ventilator using a non-inferiority trial design.

Methods:

Respiratory therapy students were recruited from an Advanced Cardiovascular Life Support class at a southern urban university. Participants conducted a 2-minute trial of ventilating a test lung alongside a metronome of 12 breaths per minute for two-min utilizing an abnormal compliance and normal compliance lung settings. Ventilation characteristics were obtained by a TSI flow meter (Laois, Ireland). Participants completed a brief survey after the ventilation exercises to assess age, race/ethnicity, sex, education, experience with BVM (scale: 0-10) and confidence with BVM (scale: 0-10). A control group was implemented using three total mechanical ventilation trials for 2 min using a test lung with abnormal compliance and normal compliance settings. Mean differences were compared between Sotair and the control group using independent samples T-tests. Statistical significance was set at P < .05. All analyses were conducted in R 3.6.2. The university Institutional Review Board approved this study.

Results:

A total of 41 respiratory therapy students participated in the ventilation exercises. Among the participants, 70.7% were female, and the majority were undergraduate students (75.6%). The mean experience level using the bag-valve mask was 6.71 (SD = 1.72), and the mean confidence level using the BVM was 8.02 (SD = 1.27). No differences were found in peak pressures between the mechanical ventilation trials and the Sotair device trials for the abnormal lung setting (P = .12) and the normal lung setting (P = .24). For the abnormal lung setting, no differences were found for tidal volume between Sotair and the mechanical ventilation trials (412.20 mL vs. 388.89 mL, respectively).

Conclusions:

There were no differences found between the manual ventilation with the Sotair device and the mechanical ventilation trials with regards to peak pressure for both normal and abnormal lung settings. Sotair ventilated at similar safety thresholds as the mechanical ventilator.