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Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins

Performance of Nursing Students in the Insertion of Supraglottic Device (Laryngeal Mask): Randomized Controlled Trial on Mannequins.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01659268
Acronym
LMANURSING
Enrollment
17
Registered
2012-08-07
Start date
2012-09-30
Completion date
2012-12-31
Last updated
2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

teaching, patient simulation, laryngeal masks, baccalaureate nursing education, teaching strategies, simulation

Brief summary

The purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and practical activity in skill lab with low-fidelity mannequin or simulation class with low-fidelity mannequin.

Detailed description

The airway control is priority in patient resuscitation. The Laryngeal Mask Airway (LMA) can minimize complications, establishing a safe airway. Is fundamental to nurse acquired skills to act in emergency situations; the simulation is a important learning tool for this, because allows a realistic environment and allows to student the possibility of training skills. Hypothesis: There difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: classroom lecture-dialogued follow of laboratory activity practice with low-fidelity mannequin or simulation in laboratory with low-fidelity mannequin? The aim of this study is compare the effect of teaching-learning strategies: classroom lecture-dialogued follow of laboratory activity practice with low-fidelity mannequin or simulation in laboratory with low-fidelity mannequin, in the acquisition of knowledge and skills to baccalaureate nursing. This is a randomized controlled trial, the population is all students of baccalaureate nursing of EERP-USP, eighth period, 69 students in total; the sample will be voluntary and composed for students that accept participate of study. The intervention group (IG) will be submitted to simulation class and the control group (CG)to exhibition-dialogued class, and practical activity in skill lab. The study will have 3 steps: 1. The participants will be recruited with letters and posters, randomized to IG or CG and follow submitted to write pre-test. 2. The GI will submitted to simulation in laboratory and de CG classroom lecture-dialogued follow of laboratory activity practice. The focus will be the airway management with emphasis in LMA. 3. All participants will be submitted to write post test and follow to practice test in simulation scenario, with medium-fidelity mannequin, which simulates human physiologic conditions. The scenario will have a appraiser with a checklist which performance scores of skills and interventions observed. The activities will be filmed and recorded. To data analysis will be used the SPSS software: descriptive statistics, chi-square test, t-test of Student.

Interventions

The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions. The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation.

OTHERExhibition-dialogued class

The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to practical activity in skill lab using the low-fidelity mannequin with duration of 35 minutes. Each subgroup will be composed of 5-6 students for the practice activity which will last 45 minutes.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* student must be in the eighth period of course; * must be registered regular in the baccalaureate nursing course.

Exclusion criteria

* absence in any step of study.

Design outcomes

Primary

MeasureTime frameDescription
Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutesScore obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE). Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent. Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent. OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score \< 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points.
Time to Conclusion of Simulation Scenario (OSCE)10 minutesThis result present the total time for execution of simulation scenario (OSCE) by the students.

Secondary

MeasureTime frameDescription
Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.10 minutes (600 sec)Time of achievement to first effective ventilation and tidal volume (adequate chest expansion). Stabilization of mannequin parameters (spO2 e HR).
Number of Attempts to Insertion of LMA10 minutes (total time of scenario)Number of attempts for insertion of LMA and obtainment of effective ventilation.

Countries

Brazil

Participant flow

Recruitment details

The strategy of data collect were Workshop Airway management in emergencies: use of laryngeal mask which dates of realization 21/11/2012 to 24/11/2012. The disclosure of event were e-mail, site of the institution and posters. Students entries were made through electronic.

Pre-assignment details

The activities were described for the students in the arrive to the workshop.

Participants by arm

ArmCount
Simulation Class
The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions. The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation.
9
Control
The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin. Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes.
8
Total17

Baseline characteristics

CharacteristicControlSimulation ClassTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants9 Participants17 Participants
Age, Continuous22.6 years
STANDARD_DEVIATION 1.69
26 years
STANDARD_DEVIATION 5.2
24.4 years
STANDARD_DEVIATION 4.2
Region of Enrollment
Brazil
8 participants9 participants17 participants
Sex: Female, Male
Female
8 Participants8 Participants16 Participants
Sex: Female, Male
Male
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 90 / 8
serious
Total, serious adverse events
0 / 90 / 8

Outcome results

Primary

Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).

Score obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE). Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent. Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent. OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score \< 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points.

Time frame: Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes

Population: The number of participants result of students that signed up in the workshop.

ArmMeasureGroupValue (MEAN)Dispersion
Simulation ClassScores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).Pre-test6.6 units on a scaleStandard Deviation 1
Simulation ClassScores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).Postest8.6 units on a scaleStandard Deviation 1.1
Simulation ClassScores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).OSCE's score8.4 units on a scaleStandard Deviation 0.89
ControlScores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).Pre-test6.5 units on a scaleStandard Deviation 0.5
ControlScores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).Postest8.4 units on a scaleStandard Deviation 0.8
ControlScores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).OSCE's score7.8 units on a scaleStandard Deviation 0.52
Primary

Time to Conclusion of Simulation Scenario (OSCE)

This result present the total time for execution of simulation scenario (OSCE) by the students.

Time frame: 10 minutes

ArmMeasureValue (MEAN)Dispersion
Simulation ClassTime to Conclusion of Simulation Scenario (OSCE)520.3 secondsStandard Deviation 157
ControlTime to Conclusion of Simulation Scenario (OSCE)479.8 secondsStandard Deviation 183.3
Secondary

Number of Attempts to Insertion of LMA

Number of attempts for insertion of LMA and obtainment of effective ventilation.

Time frame: 10 minutes (total time of scenario)

ArmMeasureValue (MEAN)Dispersion
Simulation ClassNumber of Attempts to Insertion of LMA1.56 attemptsStandard Deviation 0.63
ControlNumber of Attempts to Insertion of LMA1.63 attemptsStandard Deviation 0.74
Secondary

Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.

Time of achievement to first effective ventilation and tidal volume (adequate chest expansion). Stabilization of mannequin parameters (spO2 e HR).

Time frame: 10 minutes (600 sec)

ArmMeasureValue (MEAN)Dispersion
Simulation ClassTime for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.428.1 secondsStandard Deviation 143.6
ControlTime for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.426.5 secondsStandard Deviation 172

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026