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Clinical Trials/NCT06161389
NCT06161389
Completed
Not Applicable

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

University Hospital Padova1 site in 1 country28 target enrollmentStarted: December 11, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Applied forces on the manikin face

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Level III NICU consultants and pediatric residents

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Applied forces on the manikin face

Time Frame: 1 minute

The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

Secondary Outcomes

  • Cuff pressure(1 minute)
  • Percentage of ventilation time with leak less than 25% around the mask(1 minute)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniele Trevisanuto

Associate Professor

University Hospital Padova

Study Sites (1)

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