UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056531 |
|---|---|
| Receipt number | R000064601 |
| Scientific Title | Investigating variations in cerebral oxygen dynamics in response to acute hypotension under hypoxic inhalation. |
| Date of disclosure of the study information | 2024/12/22 |
| Last modified on | 2024/12/21 15:51:10 |
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Basic information
Public title
Cerebral oxygen dynamics for acute hypotension under hypoxia.
Acronym
Hypotension and cerebral oxygen dynamics under hypoxia.
Scientific Title
Investigating variations in cerebral oxygen dynamics in response to acute hypotension under hypoxic inhalation.
Scientific Title:Acronym
Variations in cerebral oxygen dynamics in response to hypotension under hypoxia.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the microcirculatory function of the cerebral cortex when hypotension is produced at low inhaled oxygen concentrations.
Basic objectives2
Others
Basic objectives -Others
Analysis of physiological response to hypotension.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Oxygenated hemoglobin, deoxygenated hemoglobin, total hemoglobin, and regional cerebral oxygen saturation in the cerebral cortex as measured by near-infrared spectroscopy.
Key secondary outcomes
Heart rate, blood pressure, stroke volume, total peripheral vascular resistance, oxygen consumption, carbon dioxide excretion, respiration, tidal volume, and SpO2
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hypoxia inhalation group
Interventions/Control_2
room air inhalation group
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who voluntarily apply to participate in research in response to a call for applications by e-mail.
Key exclusion criteria
Persons with circulatory disease, persons with respiratory disease, persons with head wounds who are undergoing treatment, persons with a history of stroke or other brain injury.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Tsubaki |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 SHimami-cho, Kita-ku, Niigata-city, Niigata
TEL
0252574438
tsubaki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Tsubaki |
Organization
Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 SHimami-cho, Kita-ku, Niigata-city, Niigata
TEL
0252574438
Homepage URL
tsubaki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Niigata University of Health and Welfare
Address
1398 SHimami-cho, Kita-ku, Niigata-city, Niigata
Tel
0252574455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064601
