UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019517 |
|---|---|
| Receipt number | R000022574 |
| Scientific Title | The exploratory research to clarify the clinical meanings of SPV, PPV and PI. |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2016/10/26 09:59:01 |
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Basic information
Public title
The exploratory research to clarify the clinical meanings of SPV, PPV and PI.
Acronym
The meanings of SPV, PPV and PI.
Scientific Title
The exploratory research to clarify the clinical meanings of SPV, PPV and PI.
Scientific Title:Acronym
The meanings of SPV, PPV and PI.
Region
| Japan |
Condition
Condition
Surgical anesthesia cases
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Pediatrics |
| Ophthalmology | Dermatology | Psychiatry |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Anesthesiology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Aesthetic surgery |
| Laboratory medicine | Operative medicine | Emergency medicine |
| Intensive care medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the clinical meanings of SPV, PPV and PI which are calculated from the SpO2 monitor and the arterial waveform.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the circulating blood volume
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The surgical anesthesia cases who were atatched arterial pressure line, or SpO2 monitor.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Asamoto |
Organization
The University of Tokyo Hospital
Division name
The Department of Anesthesiology and Pain Relief Center
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8668
asamoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Asamoto |
Organization
The University of Tokyo Hospital
Division name
The Department of Anesthesiology and Pain Relief Center
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-8668
Homepage URL
asamoto-tky@umin.ac.jp
Sponsor or person
Institute
The Department of Anesthesiology and Pain Relief Center
Institute
Department
Personal name
Funding Source
Organization
The Department of Anesthesiology and Pain Relief Center
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 | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We could verify that spinal anesthesia augment a pulse oximeter based perfusion index of
toes. Our finding may be a hopeful mean for detecting that spinal anesthesia made no effect.
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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2015 | Year | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022574
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/10/26 | DATA.csv |
