NCT07161752

Applied Forces During Neonatal Ventilation With Different Face Masks

Applied Forces During Neonatal Ventilation With Different Face Masks: a Randomized Crossover Manikin Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak \<25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and difficulty in obtaining a good mask seal are investigated.

Conditions

• Face Mask Ventilation in Neonatal Resuscitation

Interventions

Type	Name	Description
DEVICE	Anatomical face mask 1	Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask
DEVICE	Anatomical face mask 2	Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask
DEVICE	Round face mask	Providing face mask ventilation in a neonatal manikin using a model of round face mask

Timeline

• Start date: 2025-09-15
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-09-09
• Last updated: 2025-11-20

Locations

1 site across 1 country: Italy