UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026604 |
|---|---|
| Receipt number | R000030547 |
| Scientific Title | A comparison of clinical simulation and classical learning for airway management in medical students: a randomized controlled trial |
| Date of disclosure of the study information | 2017/03/18 |
| Last modified on | 2019/09/21 06:00:01 |
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Basic information
Public title
A comparison of clinical simulation and classical learning for airway management in medical students: a randomized controlled trial
Acronym
Clinical simulation for airway management in undergraduate students
Scientific Title
A comparison of clinical simulation and classical learning for airway management in medical students: a randomized controlled trial
Scientific Title:Acronym
Clinical simulation for airway management in undergraduate students
Region
| South America |
Condition
Condition
Medical simulation
Classification by specialty
| Medicine in general | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of clinical simulation over classical learning in the acquirement of basic skills for airway management when performed by last year medical students during the anesthesia clinical rotation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Airway management score on a validated instrument applied after 28 days of anesthesia rotation
Key secondary outcomes
rate of success of intubation and incidence of complications evaluated after 28 days of anesthesia rotation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
Students in the clinical simulation group receive a 3-hour training on airway management on the first day of their 28-day anesthesia rotation
Interventions/Control_2
Students in the control group learn de classic way with patients in the operating room, without any previous simulation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Last year medical students from the Universidad de los Andes medical school rotating in the Anesthesia Department.
Key exclusion criteria
Students with upper limbs motor deficit or students who have had a previous elective rotation in anesthesia
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Leopoldo |
| Middle name | Enrique |
| Last name | Ferrer |
Organization
Fundacion Santa Fe de Bogota
Division name
Anesthesia Department
Zip code
110111
Address
Carrera 7 No. 117-15, Bogota, Colombia
TEL
+5716030303
lfanesthesia@gmail.com
Public contact
Name of contact person
| 1st name | Leopoldo |
| Middle name | Enrique |
| Last name | Ferrer |
Organization
Fundacion Santa Fe de Bogota
Division name
Anesthesia Department
Zip code
110111
Address
Carrera 7 No. 117-15, Bogota, Colombia
TEL
+5716030303
Homepage URL
lfanesthesia@gmail.com
Sponsor or person
Institute
Fundacion Santa Fe de Bogota. Anesthesiology department
Institute
Department
Personal name
Funding Source
Organization
Anesthesia Department, Fundacion Santa Fe de Bogota
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fundacion Santa Fe de Bogota
Address
Carrera 7 No. 117-15, Bogota, Colombia
Tel
6030303
lfanesthesia@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Fundacion Santa Fe de Bogota (Bogota)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
102
Results
The simulation group obtained significantly higher scores in ventilation (6.9 in control group and 7.4 in simulation group, p=0.046) but not in endotracheal intubation (5 in control group and 5.4 in simulation group, p=0.065). Incidence of complications showed no differences statistically significant: 2 in control group and 0 in simulation group (p=0.495 for esophageal intubation and p=1 oral trauma), as did successful intubation rates (78,4 % in control group and 92,2% in simulation group, p=0.091).
Results date posted
| 2019 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030547
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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