Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin. (Neo-LMi)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Resuscitation; Newborn Asphyxia
• Intervention / Treatment: Other: Instructions A; Other: Instructions B

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru, 15072
    • Faculty of Medicine. Simulation Center.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Instructions A; The "Instructions A" is a four-step, coloured illustrated brochure with images of newborn mannequins and supplies for laryngeal mask insertion.	Other: Instructions A; "Instructions A" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins.
Active Comparator: Instructions B; The "Instructions B" is a six-step, black-and-white illustrated brochure with images of adults and supplies for laryngeal mask airway insertion.	Other: Instructions B; "Instructions B" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving effective ventilation.	Effective ventilation with a manual resuscitator involves the inflow of air into the mannequin's lungs through the laryngeal mask and raising the thorax.	Through study completion, an average of six months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing measures in the procedure.	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.	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.
Number of participants achieving a correct sequence.	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.	Through study completion, an average of six months.

Collaborators and Investigators

• Sponsor: National University of San Marcos, Peru
• Investigators: Principal Investigator: Carlos A Delgado, MD, PhD, National University of San Marcos, Peru

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: A24011761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No