UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039877 |
|---|---|
| Receipt number | R000045376 |
| Scientific Title | Reproducibility of sublingual microcirculation parameters obtained from the GlycoCheck(TM) system |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2023/04/28 11:14:06 |
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Basic information
Public title
Reproducibility of sublingual microcirculation parameters obtained from the GlycoCheck(TM) system
Acronym
Reproducibility of parameters obtained from GlycoCheck(TM)
Scientific Title
Reproducibility of sublingual microcirculation parameters obtained from the GlycoCheck(TM) system
Scientific Title:Acronym
Reproducibility of parameters obtained from GlycoCheck(TM)
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying intra- and inter-rater reproducibility of GlyoCheck(TM) Microscope Camera (microvascular Health Solutions, America) measurements in patients under general anesthesia and neuromuscular blockage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inter-rater reproducibility of PBR measured by GlycoCheck(TM)
Key secondary outcomes
Inter-rater reproducibility of VD and RBCF measured by GlycoCheck(TM)
Intra-rater reproducibility of PBR measured by GlycoCheck(TM)
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
Patients who receive scheduled surgery under general anesthesia with intubation.
Key exclusion criteria
1. A patient with wobbly tooth
2. A patient with mouth opening limitation
3. A patient who have surgical history of tongue
4. A patient with active bleeding in the mouth
5. A patient with dental injuries caused by endotracheal intubation
6. A patient determined to be inappropriate as a research subject by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Mizunoya |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
060-8648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
tokihoku0112@frontier.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Toki |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
060-8648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
tokihoku0112@frontier.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
N14 W5, Kita-ku, Sapporo
Tel
011-716-1161
crjimu@huhp.hokudai.ac.jp
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 01 | 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
50
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Observation items:
Background, Physiological data, laboratory data, Glycocheck measurements
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045376
