UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021049 |
|---|---|
| Receipt number | R000024269 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2017/01/26 11:45:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
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
Acronym
Examination about the method avoiding error of the pulse oximeter with the manicure
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akiko Kurosawa |
Organization
Toho University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
5-21-16 Omori-Nishi Ota-ku, Tokyo 143-8540, Japan
TEL
+81-3-3762-4151
yoshidaakiko45@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Kurosawa |
Organization
Toho University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
5-21-16 Omori-Nishi Ota-ku, Tokyo 143-8540, Japan
TEL
+81-3-3762-4151
Homepage URL
yoshidaakiko45@aol.com
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024269
