- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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São Paulo
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Ribeirão Preto, São Paulo, Brasilien, 14040-902
- College of Nursing at Ribeirao Preto - University of Sao Paulo
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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. |
|
Sonstiges: 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.
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).
Zeitfenster: Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes
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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
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Time to Conclusion of Simulation Scenario (OSCE)
Zeitfenster: 10 minutes
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This result present the total time for execution of simulation scenario (OSCE) by the students.
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10 minutes
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.
Zeitfenster: 10 minutes (600 sec)
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Time of achievement to first effective ventilation and tidal volume (adequate chest expansion). Stabilization of mannequin parameters (spO2 e HR). |
10 minutes (600 sec)
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Number of Attempts to Insertion of LMA
Zeitfenster: 10 minutes (total time of scenario)
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Number of attempts for insertion of LMA and obtainment of effective ventilation.
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10 minutes (total time of scenario)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Cesar E Pedersoli, MSN, College of Nursing at Ribeirao Preto - University of Sao Paulo
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EERP-2012-LMASIMULATION
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