UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accuracy of pulse oxymetries under severe hypoxia
Title of the study (Brief title)	Accuracy of pulse oxymetries under severe hypoxia
Region	Japan

Condition
Condition	Acute Mountain Scikness
Classification by specialty	Medicine in general Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Accuracy of pulse oxymetries under severe hypoxia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	SpO2 under severe hypoxia
Key secondary outcomes	SpO2 vs SaO2 under severe hypoxia

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 Other
Interventions/Control_1	hypoxia
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy volunteer
Key exclusion criteria	Subjects with diseases that hypoxia is thought to make the conditions worse such as COPD, PATE, heart failure, acute feblile illness.
Target sample size	20

Research contact person
Name of lead principal investigator	Shigeru Masuyama
Organization	Tokyo Medical University Hospital
Division name	Travellers' Medical Center
Address	6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL	+81-3-3342-6111
Email	s_masu@tokyo-med.ac.jp

Public contact
Name of contact person	Shinji Fukushima
Organization	Tokyo Medical University Hospital
Division name	Travellers' Medical Center
Address	6-7-1 Nishishinjuku shinjukuku, Tokyo
TEL	+81-3-3342-6111
Homepage URL	http://hospinfo.tokyo-med.ac.jp/shinryo/tokou/
Email	fuku789@tokyo-med.ac.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 24 Day
Anticipated trial start date	2014 Year 07 Month 28 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 07 Month 24 Day
Last modified on	2017 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017032