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Applied Forces During Neonatal Ventilation With Different Face Masks

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07161752
Enrollment
30
Registered
2025-09-09
Start date
2025-09-15
Completion date
2025-09-30
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Face Mask Ventilation in Neonatal Resuscitation

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.

Interventions

DEVICEAnatomical face mask 1

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

DEVICEAnatomical face mask 2

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

DEVICERound face mask

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

Sponsors

University Hospital Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Manikin study

Eligibility

Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Applied forces1 minuteThe force applied on the manikin head by the operator during the procedure

Secondary

MeasureTime frameDescription
Mask leak1 minuteMask leak (measured as percentage of ventilation time with leak less than 25% around the mask)
Participant opinion2 minutesParticipants' opinions on the face masks (assessed using a Likert scale, from 1 lowest grade to 5 highest grade)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026