UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041058 |
|---|---|
| Receipt number | R000046889 |
| Scientific Title | Prognostic Accuracy of the PaO2/FiO2 ratio and Oxygenation Index Assessment for Mortality in Patient with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2020/12/29 08:56:39 |
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Basic information
Public title
Prognostic Accuracy of the PaO2/FiO2 ratio and Oxygenation Index Assessment for Mortality in Patient with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-analysis
Acronym
Prognostic Accuracy of the PaO2/FiO2 ratio and Oxygenation Index Assessment for Mortality in Patient with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-analysis
Scientific Title
Prognostic Accuracy of the PaO2/FiO2 ratio and Oxygenation Index Assessment for Mortality in Patient with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Prognostic Accuracy of the PaO2/FiO2 ratio and Oxygenation Index Assessment for Mortality in Patient with Acute Respiratory Distress Syndrome: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
ARDS(Acute Respiratory Distress Syndrome)
Classification by specialty
| Medicine in general | Pneumology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the predictive reliability of the PaO2/FiO2 ratio and Oxygenation index as the predictors for prognosis among the patients with ARDS.
Basic objectives2
Others
Basic objectives -Others
Predictive reliability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome for this study will be the sensitivity and specificity of the PaO2/FiO2 ratio and Oxygenation index for the prediction of mortality in patients with ARDS.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Adult patients with a diagnosis of acute respiratory failure or acute on chronic respiratory failure and fulfilling the criteria for ALI/ARDS
Key exclusion criteria
Pediatric population as defined by study authors
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yoshimura |
Organization
School of Public Health, Kyoto University Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city, Kyoto
TEL
075-753-2431
syoshimura-ngs@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yoshimura |
Organization
School of Public Health, Kyoto University Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city, Kyoto
TEL
075-753-2431
Homepage URL
syoshimura-ngs@umin.ac.jp
Sponsor or person
Institute
ARDS Guideline Development Supervisory Committee A Area
Institute
Department
Personal name
Funding Source
Organization
None
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
School of Public Health, Kyoto University Graduate School of Medicine
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city, Kyoto
Tel
0757532431
syoshimura-ngs@umin.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
Three databases from inception through 19 June 2020.
Management information
Registered date
| 2020 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
