Skip to content

Face Mask vs Laryngeal Mask in Neonatal Resuscitation

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06952088
Acronym
ManiMask2025
Enrollment
150
Registered
2025-04-30
Start date
2025-05-01
Completion date
2025-08-31
Last updated
2025-04-30

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

Conditions

Neonatal Asphyxia, Neonatal Complication

Brief 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?

Detailed description

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.

Interventions

OTHERTraining 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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of ease of use and speed of application of the laryngeal mask versus the face mask in ventilating the newborn during simulated manikin trainingDuring 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

MeasureTime frameDescription
Comparison of differences in the time required to achieve optimal skills in using the two masksDuring 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.
Evaluation of health care personnel's level of confidence in using laryngeal mask versus face maskDuring Training sessionA pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask

Countries

Italy

Contacts

Primary ContactFrancesca Priolo
francesca.priolo@policlinicogemelli.it+390630154357
Backup ContactFrancesca Priolo
francesca.priolo@policlinicogemelli.it

Outcome results

None listed

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