UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 02 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047218