Applied Forces During Neonatal Ventilation With Different Face Masks

University Hospital Padova

Status: Completed

Conditions: Face Mask Ventilation in Neonatal Resuscitation

Treatments: Device: Anatomical face mask 1; Device: Anatomical face mask 2; Device: Round face mask

Study type: Interventional

Funder types: Other

Identifiers

NCT07161752

UNIPDNewborn25

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: Under 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Anatomical face mask 1

Experimental group

Treatment:

Device: Anatomical face mask 1

Anatomical face mask 2

Active Comparator group

Treatment:

Device: Anatomical face mask 2

Round face mask

Active Comparator group

Treatment:

Device: Round face mask