MedTrace Logo

Face Mask vs Laryngeal Mask in Neonatal Resuscitation

NCT06952088 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-04-30

No results posted yet for this study

Summary

The goal of this single-centre interventional study without medication neither device (for procedure) is to improve training of health care personnel (physicians, nurses, and midwives) on neonatal resuscitation through manikin simulation.

The main questions it aims to answer are:

* Is it possible to compare the ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin training?
* What are the differences in the time required to achieve optimal skills in using the two masks?
* What is health care personnel's level of confidence in using laryngeal mask versus face mask?

Conditions

  • Neonatal Complication
  • Neonatal Asphyxia

Interventions

OTHER

Training on Neonatal Resuscitation

Improve training of health care personnel (physicians, nurses and midwives) on neonatal resuscitation through manikin simulation using two different devices: a face mask and a laryngeal mask. Before the simulations begin, each participant will receive a brief introduction on the technical characteristics of the manikin and how to use the two masks. A stopwatch will be used to record the time required to achieve effective ventilation, defined by the expansion of one-third of the newborn manikin's rib cage. Consideration will also be given to whether corrective maneuvers will need to be performed during the use of each mask and the timing with which these maneuvers will be applied. Finally, a pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Francesca Priolo · Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-06-30
Completion
2025-08-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06952088 on ClinicalTrials.gov