NCT06161389

Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes

Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex). In neonatal manikins, ventilation with a partially or fully inflated face mask does not seem to result in differences in mask leak. The force exerted by providers to improve mask seal might result in pressure lesions and in the elicitation of the trigeminal-cardiac reflex. However, information about the applied forces is unknown.

Conditions

• Positive Pressure Ventilation
• Preterm Infants
• Apnea

Interventions

Type	Name	Description
DEVICE	Partially inflated mask	Manikin ventilation with a partially inflated mask
DEVICE	Fully inflated mask	Manikin ventilation with a fully inflated mask

Timeline

• Start date: 2023-12-11
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2023-12-07
• Last updated: 2024-04-08

Locations

1 site across 1 country: Italy