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NCT Number: NCT06952088

Face Mask vs Laryngeal Mask in Neonatal Resuscitation

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?

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

Roma, 00168, Italy

Location contact

Francesca Priolo

CONTACT

[email protected]

+390630154357

About this study

Maintaining airways and ensuring effective ventilation are the primary goals in the neonatal resuscitation algorithm.To achieve it, there are several devices, more or less invasive, such as a face mask, laryngeal Mask or tracheal tube.Among these, Laryngeal Mask can have significant advantages, including ease of use and speed of application even if used by inexperienced health personnel after a short training program.

The protocol involves the use of a neonatal manikin, which is already in the use at our simulation center. Ventilation of the manikin will be conducted using two possible masks: 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthcare Workers (physicians, nurses, and midwives) of the Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS Rome
  • Signature of an informed consent

Exclusion criteria

  • Healthcare Workers (physicians, nurses, and midwives) NOT of the Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS Rome
  • Failure to sign up for informed consent

Treatment and study plan

Training on Neonatal Resuscitation

Other

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.

Primary outcomes

  1. Comparison of ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin training

    Time frame: During Training session

    . 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.

Secondary outcomes

  1. Comparison of differences in the time required to achieve optimal skills in using the two masks

    Time frame: During Training session

    . 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.

  2. Evaluation of health care personnel's level of confidence in using laryngeal mask versus face mask

    Time frame: During Training session

    A pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Priolo

CONTACT

[email protected]

+390630154357

Francesca Priolo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Face Mask vs Laryngeal Mask in Neonatal Resuscitation: A Study on Manikins

Acronym: ManiMask2025

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Apr 30, 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.

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