UMIN-CTR Clinical Trial

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
Email	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
Email	naoyuki@oita-u.ac.jp

Sponsor
Institute	Dept of Clinical Pharmacology & Therapeutics, Oita University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041125