UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061035 |
|---|---|
| Receipt number | R000069845 |
| Scientific Title | Additional effect of pretreated formalin-fixed cadaver training in video laryngoscope intubation education for first-year postgraduate residents: a single-center randomized parallel-group pilot trial with patient-imagined self-efficacy as the primary outcome |
| Date of disclosure of the study information | 2026/03/25 |
| Last modified on | 2026/03/24 12:29:57 |
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Basic information
Public title
Pilot study of the additional effect of cadaver training in video laryngoscope intubation education for first-year postgraduate residents
Acronym
Cadaver-Added Video Laryngoscopy Education Pilot
Scientific Title
Additional effect of pretreated formalin-fixed cadaver training in video laryngoscope intubation education for first-year postgraduate residents: a single-center randomized parallel-group pilot trial with patient-imagined self-efficacy as the primary outcome
Scientific Title:Acronym
Cadaver-Added Education Trial for Video Laryngoscopy: Pilot Study
Region
| Japan |
Condition
Condition
Healthy volunteers (first-year postgraduate residents)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily examine whether adding pretreated formalin-fixed cadaver training to standard mannequin-based video laryngoscope intubation training improves the magnitude of patient-imagined self-efficacy for video laryngoscope intubation among first-year postgraduate residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in patient-imagined self-efficacy for video laryngoscope intubation. The question is: "How confident are you in performing video laryngoscope (McGRATH) intubation under the supervision of an attending physician in an actual patient setting?" A 1-10 numeric rating scale will be used. The change score will be calculated as T1-T0 in the control group and T2-T0 in the intervention group, and compared between groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Control group
Standard mannequin-based video laryngoscope intubation training using the McGRATH video laryngoscope. Each participant will perform 2 intubation attempts on a mannequin.
Interventions/Control_2
Intervention group
Standard mannequin-based video laryngoscope intubation training using the McGRATH video laryngoscope, plus additional pretreated formalin-fixed cadaver training. Each participant will perform 2 intubation attempts on a mannequin and 2 cadaver intubation attempts on 2 different pretreated formalin-fixed cadavers, 1 attempt per cadaver, according to a pre-specified rotation schedule.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
First-year postgraduate residents (PGY1) undergoing clinical training at the study institution during the study year
Participants with no prior clinical experience in tracheal intubation, or no prior clinical experience in video laryngoscope intubation
Written informed consent obtained based on free will after study explanation
Key exclusion criteria
Participants unable to attend the training session because of poor physical condition or other reasons
Pregnant participants
Participants judged inappropriate by the principal investigator for safety or operational reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Hiruma |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anesthesiology and Intensive Care Unit
Zip code
951-8520
Address
1-754 Asahimachi-Dori, Chuo-ku, Niigata City, Niigata
TEL
025-227-2338
m06a066a.med@niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Hiruma |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anesthesiology and Intensive Care Unit
Zip code
951-8520
Address
1-754 Asahimachi-Dori, Chuo-ku, Niigata City, Niigata
TEL
025-227-2338
Homepage URL
m06a066a.med@niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-754 Asahimachi-Dori, Chuo-ku, Niigata City, Niigata
Tel
025-227-2005
ethics@adm.niigata-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 25 | 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
Results
Results date posted
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069845
