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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039877
Receipt No. 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 2021/04/16

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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
Email 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
Email tokihoku0112@frontier.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Anesthesiology
Institute
Department

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
Email 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
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
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 03 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
2021 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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