Face Mask vs Laryngeal Mask in Neonatal Resuscitation (ManiMask2025)

April 23, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: health care Workers
Healthcare Workers (physicians, nurses and midwives) of Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During Training session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During Training session
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
During Training session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Francesca Priolo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7557

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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