Applied forces with partially vs. fully inflated face masks during neonatal ventilation: a randomized crossover manikin trial

Background: Positive pressure ventilation with partially (25 ml) vs. fully (35 ml) inflated face mask was compared in terms of applied forces on a newborn manikin face, cuff pressure and air leak. Methods: A crossover randomized controlled trial of face mask ventilation with partially (25 ml) vs. fully (35 ml) inflated face mask in a term neonatal manikin. The trial involved 28 neonatologists and pediatric residents. The primary outcome was the force applied to the manikin face, while the secondary outcomes were cuff pressure, ventilation time with leak <25% around the mask, and participants’ view on struggle in delivering effective ventilation, fatigue in achieving good mask seal, and satisfaction about the mask. Results: Chin and cheekbone sensors measured higher top 10th percentile of applied forces with partially vs. fully inflated face mask. Median and top 10th percentile of cuff pressures were higher with the partially inflated mask. Ventilation time with mask leak <25% was not statistically different using partially vs. fully inflated face masks, and participants reported similar opinions about the two procedures. Conclusions: The lower force applied during positive pressure ventilation with a fully inflated face mask in a neonatal manikin model may be an appealing target, nonetheless the real-life benefits should be addressed in future investigations. Registration: clinicaltrial.gov NCT0616138. Impact: Health care providers may apply different forces to improve mask seal during neonatal resuscitation. Still, data regarding applied forces with various face-mask air cushion volumes is unknown. In a neonatal manikin model, using a partially inflated (25 ml) face mask during PPV was associated to higher applied forces and cuff pressures compared to a fully inflated (35 ml) face mask. The participants reported comparable opinions about the two air cushion volumes. Applying less force on neonatal face might be a desirable objective, nonetheless future investigations should assess its real-life impact.