UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the effect that colors of the manicure give in a red/infrared light quantity received by pulse oximeter, and the precsion of oxygen saturation: An intervention study in single group of healthy adult volunteers
Title of the study (Brief title)	Optical examination of the effect that manicure gives in pulse oximeter precision
Region	Japan

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

Objectives
Narrative objectives1	We examine the degree that colors of manicure decrease red/infrared light quantity in pulse oximeter measurement, and examine the effect that manicure gives in oximetry precision
Basic objectives2	Others
Basic objectives -Others	precision of the medical equipment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The color of manicure decrease red/infrared light quantity in pulse oximeter measurement, therefore produce error in oxygen saturation
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	6-11-1 Omori-Nishi Ota-ku, Tokyo 143-8541, 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	6-11-1 Omori-Nishi Ota-ku, Tokyo 143-8541, 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 15 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024267