Face Mask vs Laryngeal Mask in Neonatal Resuscitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Training on Neonatal Resuscitation
Other interventionImprove 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: health care WorkersOther 1 intervention
Trial outcomes
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.
Time frame
During Training sessionSecondary outcomes
1
Comparison of differences in the time required to achieve optimal skills in using 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.
Time frame
During Training session2
Evaluation of health care personnel's level of confidence in using laryngeal mask versus face mask
A pseudonymous questionnaire will be administered to participants to assess their perceptions of the ease of use of each mask
Time frame
During Training sessionSponsors and contacts
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Source ClinicalTrials.gov
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