UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036103 |
|---|---|
| Receipt number | R000041125 |
| Scientific Title | A Study of Peripheral Oxygen Saturation Measured by A New Pulse Oximeter in Hypoxic Environment in a healthy person |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2022/09/08 12:52:54 |
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Basic information
Public title
A Study of Peripheral Oxygen Saturation Measured by A New Pulse Oximeter in Hypoxic Environment in a healthy person
Acronym
A Study of Peripheral Oxygen Saturation Measured by A New Pulse Oximeter in Hypoxic Environment in a healthy person
Scientific Title
A Study of Peripheral Oxygen Saturation Measured by A New Pulse Oximeter in Hypoxic Environment in a healthy person
Scientific Title:Acronym
A Study of Peripheral Oxygen Saturation Measured by A New Pulse Oximeter in Hypoxic Environment in a healthy person
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate peripheral oxygen saturation measured by A new pulse oximeter in hypoxic environment
Basic objectives2
Others
Basic objectives -Others
Adverse events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate peripheral oxygen saturation measured by A new pulse oximeter in hypoxic environment
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Hypoxic Environment
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. person who is healthy
2. BMI: >=18.5, <30.0
2. person who provides consent and signs up the consent form
Key exclusion criteria
1. baseline SpO2 < 94% at screening
2. person who has some acute or chronic disease that requires medical treatment
3. person who has abnormalities which interfere with measurements on fingers
4. person who has any abnormal findings to need treatment
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Otani |
Organization
Oita University Faculty of Medicine
Division name
Dept of Clinical Pharmacology & Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL
097-586-5952
naoyuki@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Otani |
Organization
Oita University Faculty of Medicine
Division name
Dept of Clinical Pharmacology & Therapeutics
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL
097-586-5952
Homepage URL
naoyuki@oita-u.ac.jp
Sponsor or person
Institute
Dept of Clinical Pharmacology & Therapeutics, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita medical robot and equipment Industry Council and HOKS Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
HOKS Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita university
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
Tel
097-586-6163
gcrcjimu@oita-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
| 2019 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
6
Results
Five healthy volunteers (four males and one female) were receiving inhaled medical oxygen-nitrogen gas to create a hypoxic environment.
Results date posted
| 2022 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age of patients enrolled was 35 years (range 30-36)
Participant flow
Six healthy volunteers were screened and one was excluded because his BMI was outside the threshold.
Adverse events
One patient had severe pain from the root of the nose to the bridge of the nose when wearing the mask, and the study was stopped before the hypoxic environment was reached.
Outcome measures
SpO2 was measured using a pulse oximeter.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041125
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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