UMIN-CTR Clinical Trial

Basic information
Public title	Nasal high-flow oxygen therapy in critically ill patients
Acronym	Nasal high-flow oxygen therapy in critically ill patients
Scientific Title	Nasal high-flow oxygen therapy in critically ill patients
Scientific Title:Acronym	Nasal high-flow oxygen therapy in critically ill patients
Region	Japan

Condition
Condition	respiratory failure in critically ill patients
Classification by specialty	Pneumology Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to determine clinical factors for the improvement in respiratory failure in the critically ill patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	ICU stay
Key secondary outcomes	ICU Mortality 90-day Mortality

Base
Study type	Observational

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

Intervention
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Purpose of intervention
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Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Critically ill patients received nasal high-flow oxygen therapy for respiratory failure
Key exclusion criteria	None
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigekazu Sugino
Organization	Tohoku University
Division name	Department of Anesthesiology and Perioperative Medicine
Zip code
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177321
Email	sugino@ruby.ocn.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Shigekazu Sugino
Organization	Tohoku University
Division name	Department of Anesthesiology and Perioperative Medicine
Zip code
Address	2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL	0227177321
Homepage URL
Email	sugino@ruby.ocn.ne.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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IRB Contact (For public release)
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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	2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	We found the significance of Glasgow Coma Scale after failure in high-flow oxygen therapy. The sequential use of non-invasive positive pressure ventilation in the patient with normal response can reduce the duration of ICU stay and mortality.
Results date posted
Results Delayed
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry	2016 Year 03 Month 15 Day
Date trial data considered complete	2016 Year 03 Month 15 Day
Date analysis concluded	2017 Year 04 Month 03 Day

Other
Other related information	We will assign 300 patients to the trial.

Management information
Registered date	2016 Year 09 Month 27 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027839

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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