UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051411 |
|---|---|
| Receipt number | R000058636 |
| Scientific Title | Investigation of the effect of nail art on pulse oximeter measurements and how to deal with it |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/22 09:55:53 |
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Basic information
Public title
Investigation of the effect of nail art on pulse oximeter measurements and how to deal with it
Acronym
Investigation of the effect of nail art on pulse oximeter measurements and how to deal with it
Scientific Title
Investigation of the effect of nail art on pulse oximeter measurements and how to deal with it
Scientific Title:Acronym
Investigation of the effect of nail art on pulse oximeter measurements and how to deal with it
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pulse oximeter is a monitor that can non-invasively and continuously measure arterial blood oxygen saturation (SpO2) by attaching a sensor to the fingertip. However, nail art that blocks light transmission can affect the measurements. In this study, we examine how much nail art affects SpO2 and how to deal with it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
arterial blood 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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Arterial blood oxygen saturation (SpO2) is measured for all subjects under each condition. Therefore, no assignment is made. A commercially available nail tip (false nail) coated with manicure is prepared in advance. In this study, this is called nail art. Nail art is attached to subject's nail using double-sided tape. At first, SpO2 is measured using a pulse oximeter under the condition that nothing is attached to the fingernail (using Nellcor sensor DS100A and Nellcor oxysensor IIID-25). After that, nail art is attached to subject's nail, SpO2 is measured (using DS100A and D-25). After that, probe is rotated 90 degrees (in the direction where the fingers are pinched from the left and right), and attached to subject's fingertip, and SpO2 is measured (using DS100A and D-25). In addition, SpO2 is measured under the condition that probe is attached to big toe (using D-25). Values measured under each condition are compared.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adult female aged 18-65
Key exclusion criteria
Men, underage women, SpO2 in room air less than 95%, deformity or lesions on nails, unable to wear pulse oximeter probe
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroharu |
| Middle name | |
| Last name | Maegawa |
Organization
Osaka University Dental Hospital
Division name
Dental Anesthesiology
Zip code
565-0871
Address
1-8 Yamadaoka Suita Osaka Japan
TEL
0668792972
maegawa.hiroharu.dent@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroharu |
| Middle name | |
| Last name | Maegawa |
Organization
Osaka University Dental Hospital
Division name
Dental Anesthesiology
Zip code
565-0871
Address
1-8 Yamadaoka Suita Osaka Japan
TEL
0668792972
Homepage URL
maegawa.hiroharu.dent@osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Graduate School of Dentistry, Faculty of Dentistry and Dental Hospital Ethics Review Committee
Address
1-8 Yamadaoka Suita Osaka Japan
Tel
0668795111
si-soumu-syomu@office.osaka-u.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
| 2023 | Year | 06 | Month | 23 | 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
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058636
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