UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024527 |
|---|---|
| Receipt number | R000028236 |
| Scientific Title | Evaluation of efficacy of telemedicine ICU (eICU) first in Japan |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2020/04/01 12:00:56 |
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Basic information
Public title
Evaluation of efficacy of telemedicine ICU (eICU) first in Japan
Acronym
Evaluation of efficacy of telemedicine ICU (eICU) first in Japan
Scientific Title
Evaluation of efficacy of telemedicine ICU (eICU) first in Japan
Scientific Title:Acronym
Evaluation of efficacy of telemedicine ICU (eICU) first in Japan
Region
| Japan |
Condition
Condition
Patients in Intensive Care Unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the clinical outcomes before and after eICU introduction first in Japan. Clinical outcomes including patients demographics, clinical status and vital signs, treatments, and medical economic/reimbursement information
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality
Key secondary outcomes
Length of stay, Incidence of complications, Total cost, Frequency of communication between control centre and bedside staff, Number of medical professionals needed
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
All patients in ICU with the consents
Key exclusion criteria
The ones whom investigators decides non-eligible
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Otake |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8575
otake@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Hayano |
Organization
Showa University School of Medicine
Division name
Department of Anaesthesiology and Critical Care Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8575
Homepage URL
masuika@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
JETRO, Philips Electronics Japan, Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Showa University graduate School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8000
gakuji@ofc.showa-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
昭和大学病院、昭和大学江東豊洲病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From the patients data of ICU, CCU, ER in Showa University Hospital and ICU, ER in Showa University Koto-Toyosu Hospital, patients demographics, patient clinical status, vital signs, conducted treatments and reimbursement information were pulled and compared before and after eICU introduction.
Management information
Registered date
| 2016 | Year | 10 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028236
