Performance and Acceptability of Two Self-Inflating Bag-Mask Neonatal Resuscitator Designs

Respir Care. 2015 Sep;60(9):1227-37. doi: 10.4187/respcare.03867. Epub 2015 Jul 7.


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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cardiopulmonary Resuscitation / instrumentation*
  • Equipment Design
  • Female
  • Humans
  • Infant, Newborn
  • Insufflation / instrumentation*
  • Lung / physiopathology
  • Lung Compliance
  • Male
  • Masks*
  • Patient Acceptance of Health Care
  • Respiration, Artificial / instrumentation*
  • Tidal Volume