UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038187 |
|---|---|
| Receipt number | R000043106 |
| Scientific Title | Influence of new carbon dioxide paste on "artificial Bohr effect" |
| Date of disclosure of the study information | 2019/10/05 |
| Last modified on | 2019/10/02 17:19:25 |
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Basic information
Public title
Influence of new carbon dioxide paste on "artificial Bohr effect"
Acronym
Influence of new carbon dioxide paste on "artificial Bohr effect"
Scientific Title
Influence of new carbon dioxide paste on "artificial Bohr effect"
Scientific Title:Acronym
Influence of new carbon dioxide paste on "artificial Bohr effect"
Region
| Japan |
Condition
Condition
healthy male adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether the new paste artificially produces the Bohr effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in oxyhemoglobin and deoxyhemoglobin in the forearm muscle are measured by near infrared spectroscopy (NIRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Attach an air tourniquet generally used in orthopedic surgery to the upper arm and attach the NIRS probe to the center of the forearm flexion side (non-dominant hand) with double-sided tape and surgical tape. Stop hemostasis 2 minutes after starting NIRS measurement The band was expanded to a pressure of 250 mmHg. The tourniquet was depressurized 20 minutes after the expansion, and then the measurement was continued for 5 minutes until it returned to a steady state. The measurement was terminated 27 minutes after the start of NIRS measurement. The duration of expansion was 20 minutes.
Interventions/Control_2
After the end of Experiment 1, the patient took a 10-minute rest period to recover to a steady state. After confirming the subject's numbness, pain, and absence of abnormal sensation, Experiment 2 was started. As in Experiment 1, the tourniquet was expanded to a pressure of 250 mmHg 2 minutes after the start of NIRS measurement. Carbon dioxide paste was applied to the forearm 8 minutes after pressurizing the tourniquet. The pressure was reduced and measurement was continued for 5 minutes.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Men between the ages of 20 and 30, including our students.
Key exclusion criteria
Person with heart disease, respiratory disease, peripheral nerve disease, skin disease, blood disease.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | toshihiro |
| Middle name | |
| Last name | akisue |
Organization
kobe university graduate school of health science
Division name
department of rehabilitation science
Zip code
6540142
Address
hyougokenn koubeshi sumaku tomogaaka 7tyoume 10-2
TEL
0787922555
gkoryu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | yoshitake |
| Middle name | |
| Last name | yoneda |
Organization
kobe university graduate school of health science
Division name
department of rehabilitation science
Zip code
6500017
Address
hyougokenn koubeshi tyuuouku kusunokityou 3tyoume 10-11 haiesutoookurayamakouenn501
TEL
09067307722
Homepage URL
knkvbc.pt.819.yone@gmail.com
Sponsor or person
Institute
kobe university
Institute
Department
Personal name
Funding Source
Organization
kobe university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kobe university graduate school of health science
Address
hyougokenn koubeshi sumaku tomogaaka 7tyoume 10-2
Tel
0787922555
gkoryu@med.kobe-u.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
| 2019 | Year | 10 | Month | 05 | 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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2019 | Year | 10 | Month | 02 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043106
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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