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

NCT06502327 | Completed

• 1 other identifier: A24011761
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiopulmonary Resuscitation; Newborn Asphyxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Timing measures in the procedure.

  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.

  Through study completion, an average of six months.

Study Arms (2)

Instructions A

EXPERIMENTAL

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 B

ACTIVE COMPARATOR

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

Interventions

Instructions A OTHER

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

Instructions A

Instructions B OTHER

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

Instructions B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Student not registered or withdrawn from courses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

Sponsors & Collaborators

• National University of San Marcos, Peru: lead

Study Sites (1)

Faculty of Medicine. Simulation Center.

Lima, 15072, Peru

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Carlos A Delgado, MD, PhD

  National University of San Marcos, Peru

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 16, 2024
• Study Start: October 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

PE (1)