Objective: To evaluate the physical and functional characteristics of pediatric self-inflating resuscitators.
Design: Tested under simulated clinical conditions. Results were analyzed by descriptive analysis.
Setting: A pulmonary laboratory in a university hospital.
Methods: Eight new pediatric self-inflating resuscitators were obtained from the manufacturers and evaluated for functional characteristics including: a) fraction of delivered oxygen at 10 L/min and a tidal volume of 300 mL; b) maximum stroke volume against no resistance; and c) maximum cycling frequency at -5 degrees C, 20 degrees C, and 48 degrees C. The resuscitators were also evaluated for physical characteristics, including potential for misassembly, pressure relief valves, expiratory valve leak, and inspiratory resistance.
Results: All resuscitators met the minimum standards of the Canadian Standards Association and American Standards for Testing of Materials. However, one bag cycled at only 32 breaths/min at -5 degrees C, marginally within accepted standards. Only five self-inflating resuscitators had pop-off valves. These valves malfunctioned, with valve activation occurring well above the accepted standards. Three of the self-inflating resuscitators could be misassembled for use. Four of the resuscitators were unable to deliver tidal volumes required for preoxygenation in a 20-kg child.
Conclusions: While these self-inflating resuscitators met the minimum standards, they are all unable to deliver 100% oxygen. One unit is probably not appropriate in the out-of-hospital setting when ambient temperatures are less than 0 degrees C. Those resuscitators that can be misassembled are dangerous in unskilled hands. In addition, reliance on pop-off valve activation to limit airway pressure is dangerous.