Applied Forces During Neonatal Ventilation With Different Face Masks

Not Applicable

Not yet recruiting

• Conditions: Administration of Face Mask Ventilation in Neonatal Resuscitation

• Registration Number: NCT07161752
• Lead Sponsor: University Hospital Padova

Brief Summary

This trial compares the applied forces exerted on the face of a modified preterm neonatal manikin with three different face masks. Additionally, percentages of ventilation time with mask leak \<25%, and participants' opinion about perceived applied forces, difficulty in achieving an effective ventilation, and difficulty in obtaining a good mask seal are investigated.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-09-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Level III neonatal intensive care unit (NICU) consultants, pediatric residents and anesthesiology residents

Exclusion Criteria

• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Applied forces	1 minute	The force applied on the manikin head by the operator during the procedure

Secondary Outcome Measures

Name	Time	Method
Mask leak	1 minute	Mask leak (measured as percentage of ventilation time with leak less than 25% around the mask)
Participant opinion	2 minutes	Participants' opinions on the face masks (assessed using a Likert scale, from 1 lowest grade to 5 highest grade)