UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041591 |
|---|---|
| Receipt number | R000047445 |
| Scientific Title | The effect of gel nails on pulse oximetry. Should gel nails be removed preoperatively. |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2021/03/01 09:41:47 |
* 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
The effect of gel nails on pulse oximetry.
Should gel nails be removed preoperatively.
Acronym
The effect of gel nails on pulse oximetry.
Should gel nails be removed preoperatively.
Scientific Title
The effect of gel nails on pulse oximetry.
Should gel nails be removed preoperatively.
Scientific Title:Acronym
The effect of gel nails on pulse oximetry.
Should gel nails be removed preoperatively.
Region
| Japan |
Condition
Condition
Healthy female over 20yrs
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed at determing the effect of different colors of gel nails on pulse oximetry in healthy female.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in saturation of precutaneous oxygen due to gel nails
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
| Device,equipment |
Interventions/Control_1
SpO2 monitor attached to Toe
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
American Society of Anesthesiologists class 1
Key exclusion criteria
Subjects with a history of anaemia or haemoglobinopathy or who were found to have hypothermia, low blood pressure
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Shiomi |
Organization
Matsushita Memorial Hospital
Division name
Anesthesiology
Zip code
570-8540
Address
5-55 sotojima-cho moriguchi-shi Osaka
TEL
06-6992-1231
lifeofpikjc@gmail.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Shiomi |
Organization
Matsushita Memorial Hospital
Division name
Anesthesiology
Zip code
570-8540
Address
5-55 sotojima-cho moriguchi-shi Osaka
TEL
06-6992-1231
Homepage URL
lifeofpikjc@gmail.com
Sponsor or person
Institute
Matsushita memorial hospital
Institute
Department
Personal name
Funding Source
Organization
Matsushita memorial hospital
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
Matsushita memorial hospital
Address
5-55 sotojima-cho moriguchi-shi Osaka
Tel
06-6992-1231
lifeofpikjc@gmail.com
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
| 2020 | Year | 09 | Month | 01 | 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
17
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047445
