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

Not Applicable

Completed

• Conditions: Positive Pressure Ventilation; Preterm Infants; Apnea
• Interventions: Device: Fully inflated mask; Device: Partially inflated mask

• Registration Number: NCT06161389
• Lead Sponsor: University Hospital Padova

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Study Start: 2023-12-11
• Primary Completion: 2023-12-14
• Study Completion: 2023-12-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Level III NICU consultants and pediatric residents

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fully inflated mask	Fully inflated mask	Participants will be invited to administer positive pressure ventilation by using a fully inflated mask in a neonatal manikin
Partially inflated mask	Partially inflated mask	Participants will be invited to administer positive pressure ventilation by using a partially inflated mask in a neonatal manikin

Primary Outcome Measures

Name	Time	Method
Applied forces on the manikin face	1 minute	The forces applied by the participants to the manikin face will be measured by sensors positioned on the manikin face

Secondary Outcome Measures

Name	Time	Method
Cuff pressure	1 minute	The pressure inside the mask will be measured during the procedure
Percentage of ventilation time with leak less than 25% around the mask	1 minute	The mask leak willbe measured by using a respiratory function monitoring during theprocedure

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova, University of Padova; 🇮🇹 Padova, Italy