UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accuracy of pulse oximeter to detect hypoxemia -a retrospective analysis
Title of the study (Brief title)	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	Kiyoshi Moriyama
Organization	School of medicine, Kyorin university
Division name	Department of anesthesiology
Address	6-20-2 Shinkawa, Mitaka-shi
TEL	0422-47-5511
Email	mokiyo@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Kaneko Yukari
Organization	Kyorin university
Division name	school of medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021416