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Clinical Trials/NCT06254651
NCT06254651
Completed
Not Applicable

Resuscitation Table Height for Face-mask Ventilation in Infants

University Hospital Padova1 site in 1 country28 target enrollmentStarted: February 12, 2024Last 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).

The force exerted by providers during neonatal ventilation to improve mask seal might result in pressure lesions and the elicitation of the trigeminal-cardiac reflex. The height of the resuscitation could influence the forces applied to the face and the quality of the procedure. Information about the applied forces in relation to the height of the resuscitation table 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 neonatal intensive neonatal care unit consultants and pediatric residents

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Applied forces on the manikin face

Time Frame: 1 minute after initiation of ventilation

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniele Trevisanuto

Associate Professor

University Hospital Padova

Study Sites (1)

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