UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014641 |
|---|---|
| Receipt number | 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 17:51:02 |
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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
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
| 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
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/
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017032
