UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026435
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hkinoshi@krc.biglobe.ne.jp

Sponsor
Institute Aichi Medical University, School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030372

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.