Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2025-05-01
2025-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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health care Workers
Healthcare Workers (physicians, nurses and midwives) of Neonatal Unit and Delivery Room of Fondazione Policlinico Gemelli Hospital IRCCS
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Signature of an informed consent
Exclusion Criteria
* Failure to sign up for informed consent
ALL
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Francesca Priolo
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Francesca Priolo
Role: primary
Other Identifiers
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7557
Identifier Type: -
Identifier Source: org_study_id