UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of accuracy among near-infrared oxygenation monitors using ischemia and reperfusion of upper extremities
Title of the study (Brief title)	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	Hiroyuki Kinoshita
Organization	Aichi Medical University, School of Medicine
Division name	Department of Anesthesiology
Address	1-1 Yazako Karimata, Nagakute, Aichi
TEL	0561-62-3311
Email	hkinoshi@krc.biglobe.ne.jp

Public contact
Name of contact person	Hiroyuki Kinoshita
Organization	Aichi Medical University, School of Medicine
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000030372