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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041357
Receipt No. R000047218
Scientific Title Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in septic patients receiving mechanical ventilation: a retrospective single-center study
Date of disclosure of the study information 2020/08/08
Last modified on 2020/08/08

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Basic information
Public title Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in septic patients receiving mechanical ventilation: a retrospective single-center study
Acronym Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in patients receiving mechanical ventilation
Scientific Title Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in septic patients receiving mechanical ventilation: a retrospective single-center study
Scientific Title:Acronym Impact of permissive hypoxia and hyperoxia avoidance on clinical outcomes in patients receiving mechanical ventilation
Region
Japan

Condition
Condition sepsis
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Septic patients often require mechanical ventilation, and effective ventilatory strategies can improve survival. The effects of permissive hypoxia and hyperoxia avoidance are unknown. This study aimed to examine these effects on outcomes in mechanically ventilated septic patients.
Basic objectives2 Others
Basic objectives -Others This study aimed to examine the effects of permissive hypoxia and hyperoxia avoidance on outcomes in mechanically ventilated septic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ICU mortality
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 adult septic patients requiring mechanical ventilation who had been admitted to an intensive care unit (ICU)
Key exclusion criteria child
Target sample size 213

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Umegaki
Organization Kansai Medical University
Division name Department of Anesthesiology
Zip code 573-1191
Address 2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
TEL +81-72-804-0101
Email umegakit@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Umegaki
Organization Kansai Medical University
Division name Department of Anesthesiology
Zip code 573-1191
Address 2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
TEL +81-72-804-0101
Homepage URL
Email umegakit@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
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 Kansai Medical University
Address 2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
Tel +81-72-804-0101
Email umegakit@hirakata.kmu.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 08 Month 08 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 213
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
2019 Year 06 Month 12 Day
Date of IRB
2019 Year 06 Month 12 Day
Anticipated trial start date
2019 Year 06 Month 12 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective before-after study

Management information
Registered date
2020 Year 08 Month 08 Day
Last modified on
2020 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047218

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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