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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021720
Receipt No. R000024936
Scientific Title Evaluation of the Computed Tomography missed findings in the Emergency Department of Emergency Medical Center
Date of disclosure of the study information 2016/04/01
Last modified on 2016/08/22

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Basic information
Public title Evaluation of the Computed Tomography missed findings in the Emergency Department of Emergency Medical Center
Acronym Evaluation of the Computed Tomography missed findings in the Emergency Department
Scientific Title Evaluation of the Computed Tomography missed findings in the Emergency Department of Emergency Medical Center
Scientific Title:Acronym Evaluation of the Computed Tomography missed findings in the Emergency Department
Region
Japan

Condition
Condition Emergency Disease
Classification by specialty
Radiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We reveal the risk factors of primary doctor's missed findings and discrepancies in interpretation related to treatment plan in computed tomography at the emergency department.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence of missed findings and discrepancies in interpretation related to emergency treatment plan
Key secondary outcomes Computed tomography scan parts of missed findings and discrepancies in interpretation
Details of missed findings and discrepancies in interpretation
Influence to treatment plan of missed findings and discrepancies in interpretation cases

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 Cases of ambulance transport to and walk in emergency medical center
Key exclusion criteria Cases of death at emergency department
Cases of no computed tomography
Principal investigator judged inappropriate cases
Target sample size 15000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yonemitu Takafumi
Organization Wakayama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510, Japan
TEL +81-73-441-0603
Email mirage10261976@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Yonemitu Takafumi
Organization Wakayama Medical University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 811-1 Kimiidera, Wakayama 641-8510, Japan
TEL +81-73-441-0603
Homepage URL
Email mirage10261976@mac.com

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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
Address
Tel
Email

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 和歌山県立医科大学付属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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
2016 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In order to consider the risk factor of missed findings and discrepancies in interpretation, we make a comparison between findings by medical doctors and by radiologists in computed tomography of emergency department.
The study design is the cohort study.
The way for subscription of object persons is computed tomography of emergency department from April 2013 to March 2016.
The measuring item is the presence of missed findings and discrepancies by medical doctors.

Management information
Registered date
2016 Year 03 Month 31 Day
Last modified on
2016 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024936

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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