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

University Hospital Padova

Status: Completed

Conditions: Apnea; Preterm Infants; Positive Pressure Ventilation

Treatments: Device: Fully inflated mask; Device: Partially inflated mask

Study type: Interventional

Funder types: Other

Identifiers

NCT06161389

NEOUNIPD3(2023)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Level III NICU consultants and pediatric residents

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Partially inflated mask

Experimental group

Description:

Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin

Treatment:

Device: Partially inflated mask

Fully inflated mask

Active Comparator group

Description:

Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin

Treatment:

Device: Fully inflated mask