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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cesar Eduardo Pedersoli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01659268
First received: August 2, 2012
Last updated: May 7, 2014
Last verified: December 2012
  Purpose

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.


Condition Intervention
Respiratory Failure
Other: Simulation class
Other: Exhibition-dialogued class

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Performance of Nursing Students in the Insertion of Supraglottic Device (Laryngeal Mask): Randomized Controlled Trial on Mannequins.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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 to Conclusion of Simulation Scenario (OSCE) [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    This result present the total time for execution of simulation scenario (OSCE) by the students.


Secondary Outcome Measures:
  • Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient. [ Time Frame: 10 minutes (600 sec) ] [ Designated as safety issue: Yes ]

    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 LMA [ Time Frame: 10 minutes (total time of scenario) ] [ Designated as safety issue: Yes ]
    Number of attempts for insertion of LMA and obtainment of effective ventilation.


Enrollment: 17
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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.
Other: 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659268

Locations
Brazil
College of Nursing at Ribeirao Preto - University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14040-902
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Cesar E Pedersoli, MSN College of Nursing at Ribeirao Preto - University of Sao Paulo
  More Information

No publications provided

Responsible Party: Cesar Eduardo Pedersoli, Performance of baccalaureate nursing students in insertion of supraglottic device (laryngeal mask): a randomized controlled trial in mannequins., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01659268     History of Changes
Other Study ID Numbers: EERP-2012-LMASIMULATION
Study First Received: August 2, 2012
Results First Received: August 11, 2013
Last Updated: May 7, 2014
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
teaching
patient simulation
laryngeal masks
baccalaureate nursing education
teaching strategies
simulation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014