UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the usefulness of using the pulse oximeter sideways
Acronym	Evaluation of the usefulness of using the pulse oximeter sideways
Scientific Title	Evaluation of the usefulness of using the pulse oximeter sideways
Scientific Title:Acronym	Evaluation of the usefulness of using the pulse oximeter sideways
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the equivalence of the regular pulse oximeter wearing method and the sideways wearing method in adults.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate the equivalence of SpO2 between the regular wearing method on the left index finger and the sideways wearing method on the right index finger.
Key secondary outcomes	Evaluate the equivalence of SpO2 between the regular mounting method for the left index finger and the lateral mounting method for the right index finger with the black nail tip. The relationship between the patient background / physical findings and the regular wearing method on the left index finger and the sideways wearing method on the right index finger will be examined.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Adults over 20 years old 2. Those who have obtained consent for this research by signing the consent form by the person himself / herself.
Key exclusion criteria	1. Those who cannot attach a pulse oximeter to their fingers. 2. Those who have different SpO2 values measured by the regular wearing method of the left index finger and the regular wearing method of the right index finger.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuichiro Middle name Last name Maekawa
Organization	Hamamatsu University
Division name	Department of Cardiology
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2267
Email	ymaekawa@hama-med.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Yamashita
Organization	Hamamatsu University
Division name	Department of Cardiology
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2267
Homepage URL
Email	doug1031@hama-med.ac.jp

Sponsor
Institute	Department of Cardiology, Hamamatsu University
Institute
Department

Funding Source
Organization	Department of Cardiology, Hamamatsu University
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	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel	053-435-2680
Email	rinri@hama-med.ac.jp

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	2021 Year 01 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 01 Month 11 Day
Last modified on	2021 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049052

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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