Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161389
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2023-11-29
Brief Title:
Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ForVol
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None