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

Respiratory Failure Clinical Trial

— LMANURSING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659268
• Other study ID #: EERP-2012-LMASIMULATION
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: May 7, 2014
• Start date: September 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• 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.
• Exhibition-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.

Locations

Country	Name	City	State
Brazil	College of Nursing at Ribeirao Preto - University of Sao Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes	Yes
Primary	Time to Conclusion of Simulation Scenario (OSCE)	This result present the total time for execution of simulation scenario (OSCE) by the students.	10 minutes	Yes
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).	10 minutes (600 sec)	Yes
Secondary	Number of Attempts to Insertion of LMA	Number of attempts for insertion of LMA and obtainment of effective ventilation.	10 minutes (total time of scenario)	Yes