UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035324 |
|---|---|
| Receipt number | R000040247 |
| Scientific Title | Determination of postoperative oxygen dose based on the Oxygen reserve index (ORi) |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2022/12/23 10:30:20 |
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Basic information
Public title
Determination of postoperative oxygen dose
based on the Oxygen reserve index (ORi)
Acronym
ORi and postoperative oxygen
Scientific Title
Determination of postoperative oxygen dose
based on the Oxygen reserve index (ORi)
Scientific Title:Acronym
ORi and postoperative oxygen
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessing whether the extent of hyperoxia and oxygen consumption can be reduced by
regulating the postoperative supplemental
oxygen dose based on ORi
Basic objectives2
Others
Basic objectives -Others
In comparison with the conservative treatment, the same extent of postoperative hypoxia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A low level of hyperoxia and oxygen
consumption by the reduced supplemental oxygen dose determined based on ORi
Key secondary outcomes
The same extent of postoperative hypoxia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
decreasing the postoperative supplemental oxygen dose
Interventions/Control_2
fixed dose of postoperative oxygen
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
ASA-PS 1,2
Key exclusion criteria
Cardiovascular diseases
Respiratory diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumagai Motoi |
Organization
Iwate Medical University Hospital
Division name
Department of Anaesthesiology
Zip code
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
+81-19-651-5111
bear@kxd.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumagai Motoi |
Organization
Iwate Medical University Hospital
Division name
Department of Anaesthesiology
Zip code
Address
19-1, Uchimaru, Morioka, Iwate, Japan
TEL
+81-19-651-5110(8153)
Homepage URL
bear@kxd.biglobe.ne.jp
Sponsor or person
Institute
Iwate Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University Hospital
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
Address
Tel
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
| 2019 | Year | 02 | Month | 15 | 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
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040247
