UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039989 |
|---|---|
| Receipt number | R000045069 |
| Scientific Title | Development and Reliability/Validation of a Japanese Version of Respiratory Distress Observation scale |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/04/01 18:50:53 |
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Basic information
Public title
Respiratory Distress in the ICU
Acronym
ICU Respiratory Distress Observation research
Scientific Title
Development and Reliability/Validation of a Japanese Version of Respiratory Distress Observation scale
Scientific Title:Acronym
ICU RDOS
Region
| Japan |
Condition
Condition
Ventilated patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a Japanese version of RDOS
Basic objectives2
Others
Basic objectives -Others
prevalence of respiratory distress in the ICU
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reliability and validity of the Japanese version of the RDOS
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ventilator patients >= 18 years olds
Key exclusion criteria
CPAOA
Neurological diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakuramoto |
Organization
Ibaraki Christian University
Division name
College of Nursing
Zip code
319-1295
Address
6-11-1 oomika
TEL
09012642422
h.sakuramoto@icc.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakuramoto |
Organization
Ibaraki Christian University
Division name
College of Nursing
Zip code
3191295
Address
6-11-1 oomika
TEL
09012642422
Homepage URL
h.sakuramoto@icc.ac.jp
Sponsor or person
Institute
College of Nursing, Ibaraki Christian University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Ibaraki Christian University
Address
6-11-1 oomika
Tel
09012642422
h.sakuramoto@icc.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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | 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=R000045069
