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Recruitment status Completed
Unique ID issued by UMIN UMIN000014641
Receipt No. R000017032
Scientific Title Accuracy of pulse oxymetries under severe hypoxia
Date of disclosure of the study information 2014/07/24
Last modified on 2017/10/11

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Basic information
Public title Accuracy of pulse oxymetries under severe hypoxia
Acronym Accuracy of pulse oxymetries under severe hypoxia
Scientific Title Accuracy of pulse oxymetries under severe hypoxia
Scientific Title:Acronym 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
1st name
Middle name
Last name Shigeru Masuyama
Organization Tokyo Medical University Hospital
Division name Travellers' Medical Center
Zip code
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
1st name
Middle name
Last name Shinji Fukushima
Organization Tokyo Medical University Hospital
Division name Travellers' Medical Center
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2014 Year 07 Month 24 Day
Date of IRB
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

Other
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


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