Trial Outcomes & Findings for Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins (NCT NCT01659268)
NCT ID: NCT01659268
Last Updated: 2014-06-02
Results Overview
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.
COMPLETED
NA
17 participants
Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes
2014-06-02
Participant Flow
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.
The activities were described for the students in the arrive to the workshop.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
Baseline characteristics by cohort
| Measure |
Simulation Class
n=9 Participants
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.
|
Control
n=8 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 5.2 • n=39 Participants
|
22.6 years
STANDARD_DEVIATION 1.69 • n=41 Participants
|
24.4 years
STANDARD_DEVIATION 4.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
Brazil
|
9 participants
n=39 Participants
|
8 participants
n=41 Participants
|
17 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutesPopulation: The number of participants result of students that signed up in the workshop.
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.
Outcome measures
| Measure |
Simulation Class
n=9 Participants
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.
|
Control
n=8 Participants
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.
|
|---|---|---|
|
Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).
Pre-test
|
6.6 units on a scale
Standard Deviation 1.0
|
6.5 units on a scale
Standard Deviation 0.5
|
|
Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).
Postest
|
8.6 units on a scale
Standard Deviation 1.1
|
8.4 units on a scale
Standard Deviation 0.8
|
|
Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).
OSCE's score
|
8.4 units on a scale
Standard Deviation 0.89
|
7.8 units on a scale
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: 10 minutesThis result present the total time for execution of simulation scenario (OSCE) by the students.
Outcome measures
| Measure |
Simulation Class
n=9 Participants
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.
|
Control
n=8 Participants
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.
|
|---|---|---|
|
Time to Conclusion of Simulation Scenario (OSCE)
|
520.3 seconds
Standard Deviation 157
|
479.8 seconds
Standard Deviation 183.3
|
SECONDARY outcome
Timeframe: 10 minutes (600 sec)Time of achievement to first effective ventilation and tidal volume (adequate chest expansion). Stabilization of mannequin parameters (spO2 e HR).
Outcome measures
| Measure |
Simulation Class
n=9 Participants
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.
|
Control
n=8 Participants
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.
|
|---|---|---|
|
Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.
|
428.1 seconds
Standard Deviation 143.6
|
426.5 seconds
Standard Deviation 172
|
SECONDARY outcome
Timeframe: 10 minutes (total time of scenario)Number of attempts for insertion of LMA and obtainment of effective ventilation.
Outcome measures
| Measure |
Simulation Class
n=9 Participants
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.
|
Control
n=8 Participants
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.
|
|---|---|---|
|
Number of Attempts to Insertion of LMA
|
1.56 attempts
Standard Deviation 0.63
|
1.63 attempts
Standard Deviation 0.74
|
Adverse Events
Simulation Class
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cesar Eduardo Pedersoli
College of Nursing at Ribeirão Preto, University of Sao Paulo
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place