title: Performance and Acceptability of Two Self-Inflating Bag-Mask Neonatal Resuscitator Designs.
abstract: 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.
authors.affiliation: PATH, Seattle, Washington. pcoffey@path.org.
authors.forename: Patricia S
authors.initials: PS
authors.lastname: Coffey
authors.affiliation: PATH, Seattle, Washington.
authors.forename: Eugene A
authors.initials: EA
authors.lastname: Saxon
authors.affiliation: PATH, Seattle, Washington.
authors.forename: Indira
authors.initials: I
authors.lastname: Narayanan
authors.affiliation: Department of Respiratory Therapy, Seattle Children's Hospital, and the Center for Developmental Therapeutics, Seattle Children's Hospital Research Institute, Seattle, Washington.
authors.forename: Robert M
authors.initials: RM
authors.lastname: DiBlasi
mesh_terms: D000328:Adult; D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007327:Insufflation / Q000295:instrumentation*; D008168:Lung / Q000503:physiopathology; D008170:Lung Compliance; D008297:Male; D008397:Masks; D010342:Patient Acceptance of Health Care; D012121:Respiration, Artificial / Q000295:instrumentation*; D013990:Tidal Volume
keywords: adverse intrapartum events; evaluation; medical devices; neonatal resuscitation; newborn asphyxia; ventilation