UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026604
Receipt No. 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 (Ver. 3)

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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
Email 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
Email lfanesthesia@gmail.com

Sponsor
Institute Fundacion Santa Fe de Bogota. Anesthesiology department
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030547