UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019550 |
|---|---|
| Receipt number | R000022610 |
| Scientific Title | Noninvasive and continuous total hemoglobin measurement according to the difference of the perfusion index |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2015/10/28 21:31:48 |
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Basic information
Public title
Noninvasive and continuous total hemoglobin measurement according to the difference of the perfusion index
Acronym
Noninvasive and continuous total hemoglobin measurement according to the difference of the perfusion index
Scientific Title
Noninvasive and continuous total hemoglobin measurement according to the difference of the perfusion index
Scientific Title:Acronym
Noninvasive and continuous total hemoglobin measurement according to the difference of the perfusion index
Region
| Japan |
Condition
Condition
surgical patients
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Obstetrics and Gynecology | Orthopedics | Urology |
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate precision of SpHb by difference of perfusion index.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure SpHb monitor in two places and change one PI artificially.
After that we measure blood total Hb and compare it with two places of SpHb.
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
| 0 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. written informed concent
2. The patients who require arterial total hemoglobin measurement during surgery
Key exclusion criteria
1. finger deformity or hypoperfusion which prevented the proper placement of the SpHb sensor
2. hemoglobinopathies such as sickle cell anemia or thalassemia
3. other reasons
Determined by the research staff to be unfit for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Murakawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
Address
Hikarigaoka 1, Fukushima, Fukushima, 960-1295, Japan
TEL
024-547-1342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Isosu |
Organization
Fukushima Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
Hikarigaoka 1, Fukushima, Fukushima, 960-1295, Japan
TEL
024-547-1342
Homepage URL
t-isosu@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology , Fukushima Medical University Hospital
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
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measure SpHb monitor in two places and change one PI artificially.
After that we measure blood total Hb and compare it with two places of SpHb.
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022610
