UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination about the optical validity of the side-to-side method avoiding error of measurement of the pulse oximeter with the manicure: An intervention study in single group of healthy adult volunteers
Title of the study (Brief title)	Examination about the method avoiding error of the pulse oximeter with the manicure
Region	Japan

Condition
Condition	healthy adult volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In pulse oximeter measurement, we examine the optical validity of an alternative method (attach the probe to the side of the finger), which will avoid decrement of the red/infrared light and therefor reduce error of measurement
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In pulse oximeter measurement, an alternative method (attach the probe to the side of the finger) will avoid decrement of the red/infrared light and therefor guarantee measurement accuracy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	paint the nails of subjects with manicure
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy adult volunteers
Key exclusion criteria	Cannot express intention of the participation by oneself Weak nail and/or skin Nails are not suitable for pulse oximeter measurement
Target sample size	25

Research contact person
Name of lead principal investigator	Akiko Kurosawa
Organization	Toho University School of Medicine
Division name	Department of Anesthesiology
Address	5-21-16 Omori-Nishi Ota-ku, Tokyo 143-8540, Japan
TEL	+81-3-3762-4151
Email	yoshidaakiko45@aol.com

Public contact
Name of contact person	Akiko Kurosawa
Organization	Toho University School of Medicine
Division name	Department of Anesthesiology
Address	5-21-16 Omori-Nishi Ota-ku, Tokyo 143-8540, Japan
TEL	+81-3-3762-4151
Homepage URL
Email	yoshidaakiko45@aol.com

Sponsor
Institute	Toho University School of Medicine
Institute
Department

Funding Source
Organization	NIHON KOHDEN
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 02 Month 20 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2017 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024269