Cardiopulmonary ResuscitationNeo-LMiNCT06502327
Comparison of Visual Instructions for Inserting a Laryngeal Mask in a Neonatal Mannequin.
A study testing Instructions A and Instructions B in people with Cardiopulmonary Resuscitation and Newborn Asphyxia, run by National University of San Marcos, Peru at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Newborn Asphyxia
- What is being tested?
- Instructions A and Instructions B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePeru
- Study dates
- 2 Oct 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Student not registered or withdrawn from courses
- Not having signed the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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].
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.
- Conditions
- Cardiopulmonary Resuscitation, Newborn Asphyxia
- Being tested
- Instructions A, Instructions B
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructions AOther
"Instructions A" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins.
Instructions BOther
"Instructions B" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins.
| Study group | Role | What they receive |
|---|---|---|
| Instructions A | Experimental | The "Instructions A" is a four-step, coloured illustrated brochure with images of newborn mannequins and supplies for laryngeal mask insertion. Receives: 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. Receives: Other: Instructions B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of six months.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start2 Oct 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of San Marcos, Peru
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos A. Delgado, National University of San Marcos, Peru
- Investigators
- Carlos A Delgado, MD, PhD, Principal investigator, National University of San Marcos, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502327
- Sponsor's protocol ID
- A24011761
- Acronym
- Neo-LMi
- Status last verified
- Jan 2025
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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].
- ClinicalTrials.gov ID
- NCT06502327
- Acronym / sponsor ID
- Neo-LMi / A24011761
- Conditions
- Cardiopulmonary Resuscitation, Newborn Asphyxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National University of San Marcos, PeruUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructions A | Experimental | Other: Instructions AThe "Instructions A" is a four-step, coloured illustrated brochure with images of newborn mannequins and supplies for laryngeal mask insertion. |
| Instructions B | Active comparator | Other: Instructions BThe "Instructions B" is a six-step, black-and-white illustrated brochure with images of adults and supplies for laryngeal mask airway insertion. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Student not registered or withdrawn from courses
- Not having signed the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructions A"Instructions A" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins. | Other | Instructions A |
| Instructions B"Instructions B" are printed visual instructions for health students for inserting a laryngeal mask into neonatal mannequins. | Other | Instructions B |
Primary outcome
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.
2 secondary outcomes
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.
Number of participants achieving a correct sequence.
Time frame: Through study completion, an average of six months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Delgado, MD, PhD principal investigator
National University of San Marcos, Peru
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructions A and Instructions B in people with Cardiopulmonary Resuscitation and Newborn Asphyxia, run by National University of San Marcos, Peru at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving effective ventilation. (time frame: Through study completion, an average of six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.