UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043317 |
|---|---|
| Receipt number | R000048055 |
| Scientific Title | The prevalence of tracheal diverticulum and the impact of tracheal intubation |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2022/09/08 11:59:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prevalence of tracheal diverticulum and the impact of tracheal intubation
Acronym
The prevalence of tracheal diverticulum and the impact of tracheal intubation
Scientific Title
The prevalence of tracheal diverticulum and the impact of tracheal intubation
Scientific Title:Acronym
The prevalence of tracheal diverticulum and the impact of tracheal intubation
Region
| Japan |
Condition
Condition
tracheal diverticulum
Classification by specialty
| Pneumology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to survey the prevalence of tracheal diverticulum in the community and the incidence of tracheal diverticulum after tracheal intubation during general anesthesia
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence of tracheal diverticulum
Key secondary outcomes
incidence of tracheal after tracheal intubation during general anesthesia, location and maximum diameter of tracheal diverticulum, prevalence of bronchial diverticulum
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
patients who underwent chest CT in our institution between January 2018 to July 2020
Key exclusion criteria
patients who don't have CT images including entire length of trachea or minimum CT slice thickness >3.0mm
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Nagano Prefectural Shinshu Medical Center
Division name
The Department of Anesthesiology
Zip code
382-8577
Address
1332 Suzaka, Suzaka City, Nagano
TEL
026-245-1650
m06095km@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Nagano Prefectural Shinshu Medical Center
Division name
The Department of Anesthesiology
Zip code
382-8577
Address
1332 Suzaka, Suzaka City, Nagano
TEL
026-245-1650
Homepage URL
m06095km@jichi.ac.jp
Sponsor or person
Institute
The Department of Anesthesiology, Nagano Prefectural Shinshu Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Institutional Review Board, Nagano Prefectural Shinshu Medical Center
Address
1332 Suzaka, Suzaka City, Nagano
Tel
026-245-1650
shinshu-med-cent@pref-nagano-hosp.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
| 2021 | Year | 02 | Month | 15 | 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
5854
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The result were presented at The 69th Annual Meeting of the Japanese Society of Anesthsiologists, June 17th, 2022 and are now preparing for publishing.
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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
using X-ray viewer software on electrical medical record and displaying opt-out document in our institution
Management information
Registered date
| 2021 | Year | 02 | Month | 13 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048055
