UMIN-CTR Clinical Trial

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
Email	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
Email	syoshimura-ngs@umin.ac.jp

Sponsor
Institute	ARDS Guideline Development Supervisory Committee A Area
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046889