Skip to main content
OpenTrials
Completed

NCT Number: NCT07161752

Applied Forces During Neonatal Ventilation With Different Face Masks

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Face Mask Ventilation in Neonatal Resuscitation

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Università di Padova

Padova, 35128, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to participate

Treatment and study plan

Anatomical face mask 1

Device

Providing face mask ventilation in a neonatal manikin using a model of anatomical face mask

Anatomical face mask 2

Device

Providing face mask ventilation in a neonatal manikin using another model of anatomical face mask

Round face mask

Device

Providing face mask ventilation in a neonatal manikin using a model of round face mask

Primary outcomes

  1. Applied forces

    Time frame: 1 minute

    The force applied on the manikin head by the operator during the procedure

Secondary outcomes

  1. Mask leak

    Time frame: 1 minute

    Mask leak (measured as percentage of ventilation time with leak less than 25% around the mask)

  2. Participant opinion

    Time frame: 2 minutes

    Participants' opinions on the face masks (assessed using a Likert scale, from 1 lowest grade to 5 highest grade)

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

Applied Forces During Neonatal Ventilation With Different Face Masks: a Randomized Crossover Manikin Study.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.