UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052701 |
|---|---|
| Receipt number | R000057319 |
| Scientific Title | Motion analysis during tracheal intubation at clinical situation using motion analysis software |
| Date of disclosure of the study information | 2023/11/11 |
| Last modified on | 2024/05/07 10:59:22 |
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Basic information
Public title
Motion analysis during tracheal intubation at clinical situation using motion analysis software
Acronym
Motion analysis during tracheal intubation at clinical situation using motion analysis software
Scientific Title
Motion analysis during tracheal intubation at clinical situation using motion analysis software
Scientific Title:Acronym
Motion analysis during tracheal intubation at clinical situation using motion analysis software
Region
| Japan |
Condition
Condition
tracheal intubation
Classification by specialty
| Anesthesiology | Operative medicine | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the operating room, for patients undergoing tracheal intubation for general anesthesia, participants skilled in tracheal intubation and non-skilled participants perform tracheal intubation using a Macintosh laryngoscope and a video laryngoscope. Record the situation on video. The data will be analyzed using motion analysis software, and the movements and usage of the head, arms, and hands of the participants, as well as the tracheal intubation time, will be analyzed in relation to the proficiency level of the tracheal intubation operation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
movement of the participant's head, upper extremities, arms, and laryngoscope during the endotracheal intubation procedure
Key secondary outcomes
tracheal intubation time
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
a) Doctors working at St. Marianna University Hospital
b) Those who have experience of tracheal intubation for patient
c) Those who read the explanation on the attached sheet, understand the basic purpose of this research, and wish to participate voluntarily
d) Participants who have received sufficient explanation about this study, and who have given written informed consent based on their full understanding
Key exclusion criteria
In case of judged to be unsuitable as a participant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Hamabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
0449778111
k2hamabe@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hamabe |
Organization
St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
0449778111
Homepage URL
k2hamabe@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa, Japan
Tel
0449778111
chikenjimu@marianna-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
| 2023 | Year | 11 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no particular
Management information
Registered date
| 2023 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057319
