ClinicalTrials.gg
CompletedNCT06502327Neo-LMiUpdated Jan 10, 2025

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

An interventional study of Instructions A and Instructions B in Cardiopulmonary Resuscitation and Newborn Asphyxia, sponsored by National University of San Marcos, Peru. Completed at 1 site in Peru. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by National University of San Marcos, Peru · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiopulmonary Resuscitation
  • Newborn Asphyxia

Browse trials for

03

In context

Asphyxia Neonatorum

106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.

This study's enrollment of 62 is below the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.

Browse Asphyxia Neonatorum studies →

Lead sponsor

National University of San Marcos, Peru is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Student not registered or withdrawn from courses
  • Not having signed the
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherInstructions A

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

  • OtherInstructions B

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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

    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.

  2. 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.

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

07

Study locations

1 site
  • Faculty of Medicine. Simulation Center.
    Lima, 15072, Peru
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06502327
Lead sponsor
National University of San Marcos, Peru
Responsible party
Carlos A. Delgado (Associate Research Professor, National University of San Marcos, Peru) — Principal investigator
First posted
Jul 16, 2024
Start date
Oct 2, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Jan 10, 2025

Study contacts

Carlos A Delgado, MD, PhD
principal investigator · National University of San Marcos, Peru

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion