UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021001 |
|---|---|
| Receipt number | R000024240 |
| Scientific Title | The efficacy of Root& Oxygen Reserve Index for the respiratory management in general anesthesia. |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2021/02/15 18:48:47 |
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Basic information
Public title
The efficacy of Root& Oxygen Reserve Index for the respiratory management in general anesthesia.
Acronym
The efficacy of Root Oxygen Reserve Index.
Scientific Title
The efficacy of Root& Oxygen Reserve Index for the respiratory management in general anesthesia.
Scientific Title:Acronym
The efficacy of Root Oxygen Reserve Index.
Region
| Japan |
Condition
Condition
General anesthesia case
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the elucidation of the efficacy of Oxygen Reserve Index on respiratory management in general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of hypoxic event in general anesthesia.
Key secondary outcomes
The duration of hypoxic event, The difference of maximum - minimum SpO2, Correlation between Oxygen Reserve Index and PaO2 (Perfusion index < 0.5 and more over 0.5), The incidence of respiratory complication at postoperative 24-hours period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The Root is applied and the patients are managed to maintain Oxygen Reserve Index 0.25 - 1.0.
Interventions/Control_2
Conventional SpO2 monitor is only applied.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who receive general anesthesia.
Key exclusion criteria
The patients that the sensor cannot apply, low perfusion and the anesthesiologists determine inappropriate for this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hirata |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
0608543
Address
South 1, West 16, Chuo-ku Sapporo, Hokkaido
TEL
011-611-2111
naohirata@mac.com
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Hirata |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
0608543
Address
South 1, West 16, Chuo-ku Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
naohirata@mac.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine, Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine, Anesthesiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Sapporo Medical School of University Hospital
Address
291, South 1, West 16, Chuo-ku, Sapporo
Tel
011-611-2111
chakitomohiro0728@yahoo.co.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
| 2016 | Year | 02 | Month | 12 | 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
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024240
| 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 |
