UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017290 |
|---|---|
| Receipt number | R000020060 |
| Scientific Title | Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia |
| Date of disclosure of the study information | 2015/04/28 |
| Last modified on | 2018/06/24 22:55:59 |
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Basic information
Public title
Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia
Acronym
Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia
Scientific Title
Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia
Scientific Title:Acronym
Comparison of the value of near infra-red oxygenation monitor and regional saturation under general anesthesia
Region
| Japan |
Condition
Condition
Patients whom were scheduled to operation
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Cardiovascular surgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the purpose is to comparison the value of NIRO (Near Infra-Red Oxygenation monitor) and rSO2 (resional saturation) by INVOS under general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of O2Hb and rSO2, analysis of arterial blood sample, correlation between SvO2 and O2Hb or rSO2
Key secondary outcomes
the change of rSO2, analysis of arterial blood sample,correlation between SvO2 and O2Hb or rSO2, postoperative complication contained brain function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
NIRO was used during operation
Interventions/Control_2
INVOS was used during operation
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 15 to 90, whom are necessary to use the monitoring of regional saturation
Key exclusion criteria
Patients refused the participation of the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takeda |
Organization
Sapporo Medical University School of Medicine
Division name
Hospital Division
Zip code
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
hiroshi.takeda@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Sapporo Medical University School of Medicine
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
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
| 2015 | Year | 04 | Month | 28 | 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
| 2014 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 27 | Day |
Last modified on
| 2018 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020060
