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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018501
Receipt No. R000021416
Scientific Title Accuracy of pulse oximeter to detect hypoxemia -a retrospective analysis
Date of disclosure of the study information 2015/07/31
Last modified on 2019/01/31

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Basic information
Public title Accuracy of pulse oximeter to detect hypoxemia -a retrospective analysis
Acronym Accuracy of pulse oximeter to detect hypoxemia
Scientific Title Accuracy of pulse oximeter to detect hypoxemia -a retrospective analysis
Scientific Title:Acronym Accuracy of pulse oximeter to detect hypoxemia
Region
Japan

Condition
Condition Patients admitted to the intensive care unit
Classification by specialty
Medicine in general Surgery in general Anesthesiology
Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We compare the accuracy of 2 pulse oximeters to detect hypoxemia in patients admitted to the surgical and general intensive care unit
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We compare SpO2 minus SaO2 between 2 pulse oximeters made by 2 different companies.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria This study enrolls all the patients admitted to the surgical and general intensive care unit between November 2012 to March 2015.
Key exclusion criteria No
Target sample size 4500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Moriyama
Organization School of medicine, Kyorin university
Division name Department of anesthesiology
Zip code
Address 6-20-2 Shinkawa, Mitaka-shi
TEL 0422-47-5511
Email mokiyo@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaneko Yukari
Organization Kyorin university
Division name school of medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-shi
TEL 0422-47-5511
Homepage URL
Email igakus@ks.kyorin-u.ac.jp

Sponsor
Institute Department of anesthesiology, Kyorin university school of medicine
Institute
Department

Funding Source
Organization Department of anesthesiology, Kyorin university school of medicine
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

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results 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 Main results already published
Date of protocol fixation
2015 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective observational study

Management information
Registered date
2015 Year 07 Month 31 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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