UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026435 |
|---|---|
| Receipt number | R000030372 |
| Scientific Title | Comparison of accuracy among near-infrared oxygenation monitors using ischemia and reperfusion of upper extremities |
| Date of disclosure of the study information | 2017/03/07 |
| Last modified on | 2018/03/08 09:34:44 |
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Basic information
Public title
Comparison of accuracy among near-infrared oxygenation monitors using ischemia and reperfusion of upper extremities
Acronym
Comparison of accuracy among near-infrared oxygenation monitors
Scientific Title
Comparison of accuracy among near-infrared oxygenation monitors using ischemia and reperfusion of upper extremities
Scientific Title:Acronym
Comparison of accuracy among near-infrared oxygenation monitors
Region
| Japan |
Condition
Condition
Ischemic diseases in upper extremities
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study was designed to examine how different tissue oxygenation parameters derived from NIRS reflect the changes in the forearm blood flow according to the brief ischemia and the subsequent reperfusion, and whether values of these parameters move in parallel with the medial and lateral sides of forearm blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
How different tissue oxygenation parameters derived from NIRS reflect the changes in the forearm blood flow according to the brief ischemia and the subsequent reperfusion.
Key secondary outcomes
Whether values of these parameters move in parallel with the medial and lateral sides of forearm blood flow.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
In volunteers, brief ischemia was achieved using a blood pressure cuff applied to the examined upper arm at 180 mmHg. Continuous measurements of medial (or lateral) TOI in combination were performed (Trial 1) from the immediately before brief ischemia to 10 minutes after the release of a blood pressure cuff. Thirty minutes after the trial 1, the medial and lateral sides exchanged, and the continuous measurements were repeated (Trial 2).
Interventions/Control_2
In volunteers, brief ischemia was achieved using a blood pressure cuff applied to the examined upper arm at 180 mmHg. Continuous measurements of lateral (or medial) rSO2 were performed at the same time (Trial 1) from the immediately before brief ischemia to 10 minutes after the release of a blood pressure cuff. Thirty minutes after the trial 1, the medial and lateral sides exchanged, and the continuous measurements were repeated (Trial 2).
Interventions/Control_3
In volunteers, brief ischemia was achieved using a blood pressure cuff applied to the examined upper arm at 180 mmHg. Continuous measurements of forearm blood flow were performed for medial and lateral side from the immediately before brief ischemia to 10 minutes after the release of a blood pressure cuff.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
Subjects with the history of redness or rash on their forearm were excluded from this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kinoshita |
Organization
Aichi Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-1 Yazako Karimata, Nagakute, Aichi
TEL
0561-62-3311
hkinoshi@krc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kinoshita |
Organization
Aichi Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-1 Yazako Karimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
hkinoshi@krc.biglobe.ne.jp
Sponsor or person
Institute
Aichi Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University, School of Medicine
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
Address
Tel
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
| 2017 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The tissue oxygenation index (TOI), regional saturation of oxygen (rSO2), skin tissue oxygenation (StO2), and FBF values were evaluated in the forearm. Medial rSO2 values at 1 to 3 minutes after the termination of brief ischemia were higher than lateral rSO2 and respective TOI values. FBF and StO2 values quickly increased according to the cessation of brief ischemia, whereas the medial and lateral values did not differ during and after the brief ischemia. TOI and StO2, but not rSO2, reflected changes in FBF of both medial and lateral sides simultaneously in response to the reperfusion after brief ischemia. The muscle tissue oxygenation during reperfusion favors the use of TOI and StO2, but not rSO2, as the surrogate parameter.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Kinoshita H, Akahori T, Nakamura E, Okawa H, Kawahito S, Kitahata H, Fujiwara Y: Tissue oxygenation index reflects changes in forearm blood flow after brief ischemia. J Med Invest 2017; 64: 228-232.
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030372
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