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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name