UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010745 |
|---|---|
| Receipt number | R000012553 |
| Scientific Title | Reliability of New Non-invasive hemoglobin monitoring with calibration function |
| Date of disclosure of the study information | 2013/05/16 |
| Last modified on | 2018/05/21 18:09:44 |
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Basic information
Public title
Reliability of New Non-invasive hemoglobin monitoring with calibration function
Acronym
Reliability of New Non-invasive hemoglobin monitoring
Scientific Title
Reliability of New Non-invasive hemoglobin monitoring with calibration function
Scientific Title:Acronym
Reliability of New Non-invasive hemoglobin monitoring
Region
| Japan |
Condition
Condition
surgical patients
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Vascular surgery |
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the new noninvasive hemoglobin monitoring with calibration function in surgical patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the arterial heoblobin and non-invasive hemoglobin (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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. adult surgical patients
2. written informed consent
3. surgical patientsin need of arterial blood draws for standard anesthetic care
4. estimated blood loss is more than 25% of blood volume
Key exclusion criteria
1. peripheral arterial disease patients
2. patihents who have problem of the fingertip
3. anemia due to abnormal hemoblobin
4. patients whom resercher think inapporpriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Hoka |
Organization
Kyushu University
Division name
Department of Anesthesia and Critical Care Medicine
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5714
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyushu University Hospital
Division name
Department of Anesthesia and CCM
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesia and CCM, Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia and CCM, Kyushu 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0952818014001834?via%3Dihub
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
| 2013 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 15 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 15 | Day |
Other
Other related information
After obtaining written informed consent, this prospective and observational study is conducted.
Besides routine monitors, direct radial arterial blood pressure and SpHb are monitored. SpHb is measured with New Radical-7; (Masimo Corporation, Irvine, CA, USA)
Time-matched SpHb is recorded only when each anesthesiologist decide to need arterial blood gas analysis for standard care. Blood samples are drawn intermittently and analyzed using Co-oximeter (Radiometer ABL 800; Radiometer, Copenhagen, Denmark).
We investigate the differences between SpHb and arterial Hb at each paired measurement.
Management information
Registered date
| 2013 | Year | 05 | Month | 16 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012553
