Face Mask vs Laryngeal Mask in Neonatal Resuscitation

NCT06952088 | Not Yet Recruiting

• 1 other identifier: 7557
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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?

Conditions

Neonatal Complication; Neonatal Asphyxia

Outcome Measures

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

  . 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 Outcomes (2)

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

  During Training session

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

  During Training session

Study Arms (1)

health care Workers

OTHER

Healthcare Workers (physicians, nurses and midwives) of Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS

Other: Training on Neonatal Resuscitation

Interventions

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.

health care Workers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Francesca Priolo

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Priolo

CONTACT

+390630154357; francesca.priolo@policlinicogemelli.it

Francesca Priolo

CONTACT

francesca.priolo@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: May 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

IT (1)