- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659268
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins (LMANURSING)
Performance of Nursing Students in the Insertion of Supraglottic Device (Laryngeal Mask): Randomized Controlled Trial on Mannequins.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- The participants will be recruited with letters and posters, randomized to IG or CG and follow submitted to write pre-test.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14040-902
- College of Nursing at Ribeirao Preto - University of Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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. |
Other: Exhibition-dialogued class
Students will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, each subgroup composed of 4-5 students will go to the and practical activity in skill lab using the low-fidelity mannequin for 35 minutes.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).
Time Frame: Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes
|
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
|
Time to Conclusion of Simulation Scenario (OSCE)
Time Frame: 10 minutes
|
This result present the total time for execution of simulation scenario (OSCE) by the students.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.
Time Frame: 10 minutes (600 sec)
|
Time of achievement to first effective ventilation and tidal volume (adequate chest expansion). Stabilization of mannequin parameters (spO2 e HR). |
10 minutes (600 sec)
|
Number of Attempts to Insertion of LMA
Time Frame: 10 minutes (total time of scenario)
|
Number of attempts for insertion of LMA and obtainment of effective ventilation.
|
10 minutes (total time of scenario)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cesar E Pedersoli, MSN, College of Nursing at Ribeirao Preto - University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EERP-2012-LMASIMULATION
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