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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043317
Receipt No. 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 2021/02/16

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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 >2.5mm
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
Email 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
Email m06095km@jichi.ac.jp

Sponsor
Institute The Department of Anesthesiology, Nagano Prefectural Shinshu Medical Center
Institute
Department

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
Email 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
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 No longer recruiting
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
2021 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048055

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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