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Completed

NCT Number: NCT06502327

Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin.

This research project compares the effectiveness of two visual instructions for inserting laryngeal masks. Researchers will assess the procedure performed by undergraduate health students on neonatal mannequins. The student's performance will be evaluated by assessing the results, timing and sequence recorded in videos during the simulation. An Ethical Committee reviewed and approved the protocol.

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Key information

Conditions

Cardiopulmonary Resuscitation Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Newborn Asphyxia

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine. Simulation Center.

Lima, 15072, Peru

About this study

This research project compares the effectiveness of two visual instructions for inserting laryngeal masks. Researchers will assess the procedure performed by undergraduate health students on neonatal mannequins. The students will participate voluntarily after signing an informed consent. The participating students will be randomly assigned to one of the two groups, each receiving a different visual instruction. The student's performance will be evaluated by assessing the results, timing and sequence recorded in videos during the simulation. An Ethical Committee reviewed and approved the protocol. The Universidad Nacional Mayor de San Marcos funded the investigation through the 2024 grant contest for Research Groups.

The project aims to provide evidence of the advantages of visual instructional methods for inserting laryngeal masks, which contribute to advancing knowledge in medical training and neonatal procedures. The results are expected to inform the selection of more effective educational materials, thus improving student preparation and neonatal care. This research has the potential to bridge the gap between academic theory and clinical practice, benefiting both society and scientific development in neonatal medicine.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Students, Health Occupations
  • In the last year of studies at the University of San Marcos or any other similar University, and having basic knowledge of neonatal procedures.

Exclusion criteria

  • Student not registered or withdrawn from courses
  • Not having signed the informed consent

Treatment and study plan

Instructions A

Other

"Instructions A" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins.

Instructions B

Other

"Instructions B" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins.

Primary outcomes

  1. Number of participants achieving effective ventilation.

    Time frame: Through study completion, an average of six months.

    Effective ventilation with a manual resuscitator involves the inflow of air into the mannequin's lungs through the laryngeal mask and raising the thorax.

Secondary outcomes

  1. Timing measures in the procedure.

    Time frame: From the start of the review of instructions to the verification of chest expansion or failure to achieve chest expansion with at least three ventilation, whichever came first, assessed up to 10 minutes.

    The time, as recorded in a video, captures the entire process, including the required time to review instructions, the moment of laryngeal mask placement, the start of positive pressure ventilation, and the verification of the mannequin's chest expansion with ventilation.

  2. Number of participants achieving a correct sequence.

    Time frame: Through study completion, an average of six months.

    The correct sequence, involves the initial use of a syringe to extract air, the placement of the laryngeal mask, and the final use of the syringe to inject air, before ventilation with a manual resuscitator.

Sponsors and collaborators

Lead sponsor

National University of San Marcos, Peru

Other

Registry information

Official study title

Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin [Comparación de Instructivos Para inserción de máscara laríngea en maniquí Neonatal].

Acronym: Neo-LMi

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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