Face Mask vs Laryngeal Mask in Neonatal Resuscitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Training on Neonatal Resuscitation.
- Who it may be relevant to
- Registry conditions: Neonatal Complication, Neonatal Asphyxia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Face Mask vs Laryngeal Mask in Neonatal Resuscitation: A Study on Manikins
Overview
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
- 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
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Comparison of differences in the time required to achieve optimal skills in using the two masks [Time frame: During Training session]
- Evaluation of health care personnel's level of confidence in using laryngeal mask versus face mask [Time frame: During Training session]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS; UOC Neonatologia — Roma
Identifiers
NCT: NCT06952088 · 7557