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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042966
Receipt No. R000049052
Scientific Title Evaluation of the usefulness of using the pulse oximeter sideways
Date of disclosure of the study information 2021/01/12
Last modified on 2021/01/11

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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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