UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011909 |
|---|---|
| Receipt number | R000013912 |
| Scientific Title | Validation of noninvasive hemoglobin monitoring with calibration function |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2016/04/01 16:58:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation of noninvasive hemoglobin monitoring with calibration function
Acronym
Validation of noninvasive hemoglobin monitoring with calibration function
Scientific Title
Validation of noninvasive hemoglobin monitoring with calibration function
Scientific Title:Acronym
Validation of noninvasive hemoglobin monitoring with calibration function
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 the new machine of the non-invasive hemoglobin monitoring with caliblation function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare hemoglobin of arterial blood and two type non-invasive hemoglobins(SpHb and Corrected 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 Unversity
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 Unversity 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
Department of Anesthesiology, Fukushima Medical University Hospital
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（福島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results and Discussion: 52 pairs of data were collected. Bland-Altman analysis showed the 95% limits of agreement(LOA) to be -0.89 to 1.85 g/dl, with a bias of -0.48 g/dl for the difference between SpHb and tHb without in vivo adjustment. In vivo adjustment did not improve the accuracy of SpHb. SpHb is reported to have relatively poor correlation in a dynamic situation such as massive bleeding, in which in vivo adjustment may have its efficacy and this is to be investigated further.
Conclusion: In vivo adjustment did not improve the accuracy of SpHb.
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 | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. All patients provided written informed consent.
2. After each patient was admitted to the operating room, two SpHb sensors, connected to two types Radical-7 Pulse CO-Oximeter (Masimo Corp., Irvine, CA, USA) was applied to the fingers.
3. Following induction of general anesthesia, an arterial catheter was placed for arterial blood pressure monitoring and blood sampling.
4. When clinically required, blood was drawn from the arterial catheter and analyzed for tHb using a bench top blood gas analyzer (RapidLab 860, Siemens,
Munich, Germany). SpHb at the time of blood draw was recorded for comparison to the tHb value.
Management information
Registered date
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2016 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013912
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
