Background: A self-inflating bag-mask device is specified by international policy guidelines as standard prototype of care for newborn resuscitation. Our hypothesis is that a new bag-mask design would be as effective and easy to use as a standard, self-inflating resuscitation bag-mask.
Methods: We conducted a comparative evaluation of the performance and acceptability of the Laerdal 220-mL resuscitator with a size-1 mask (NeoNatalie) and a Laerdal prototype Upright resuscitator with a modified mask. Participants evaluated the devices in random order using a commercially available test lung and training mannikin with an integrated chest-rise module. The test lung was configured with healthy and sick newborn lung mechanics. Two user groups participated: (1) frequent users who had used manual resuscitators to resuscitate infants and (2) infrequent users who received competency-based training and had not previously used manual resuscitators to resuscitate infants.
Results: Thirty-eight individuals participated in the study during March 2013. Both resuscitators are capable of delivering the minimum required tidal volumes to newborns. The Upright device provided a significant reduction in the percentage of inadequate ventilations (< 12.5 mL) compared with the NeoNatalie. Although the test sequences with low-compliance lung settings showed no difference in the percentage of excessive ventilations (> 37.5 mL) between the Upright and NeoNatalie, the test sequences with normal-compliance lung settings showed a higher percentage of excessive ventilations with both, and the increase was greater with the Upright than with the NeoNatalie (85.92% vs 71.39%, P < .001). The subjective acceptability and disassembly/reassembly tests were supportive of the new device design.
Conclusions: The performance and acceptability of the Upright device in this user population suggest that the device may be suitable for effective ventilation by infrequent users in low-resource settings. The Upright device should be tested in such a setting.
Keywords: adverse intrapartum events; evaluation; medical devices; neonatal resuscitation; newborn asphyxia; ventilation.
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