UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010487 |
|---|---|
| Receipt number | R000012202 |
| Scientific Title | The accuracy of non-invasive measurement of hemoglobin concentration under general anesthesia |
| Date of disclosure of the study information | 2013/04/15 |
| Last modified on | 2015/10/25 12:33:14 |
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Basic information
Public title
The accuracy of non-invasive measurement of hemoglobin concentration under general anesthesia
Acronym
The accuracy of non-invasive measurement of hemoglobin concentration under general anesthesia
Scientific Title
The accuracy of non-invasive measurement of hemoglobin concentration under general anesthesia
Scientific Title:Acronym
The accuracy of non-invasive measurement of hemoglobin concentration under general anesthesia
Region
| Japan |
Condition
Condition
patients who are planned to undergo operations under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of non-invasive measurement of hemoglobin concentration by pulse co-oximetry under general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We are going to evaluate the correlation between SPHb and Hb measured on arterial blood samples.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients, who are planned to undergo operations in which more than 500ml of hemorrhage is anticipated and invasive blood pressure monitoring is needed.
Key exclusion criteria
Patients who are not replaced arterial catheter during surgery.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7 Asahi-machi Abeno-ku Osaka Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
TEL
06-6645-2186
Homepage URL
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate 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
| 2013 | Year | 04 | Month | 15 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Bland and Altman analysis between non-invasively measured Hb and those measured by arterial catheters
Management information
Registered date
| 2013 | Year | 04 | Month | 13 | Day |
Last modified on
| 2015 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012202
