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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024179
Receipt No. R000027839
Scientific Title Nasal high-flow oxygen therapy in critically ill patients
Date of disclosure of the study information 2016/10/01
Last modified on 2017/03/29

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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
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
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

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
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
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
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
Registered date File name

Research case data
Registered date File name


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