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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016699
Receipt No. R000019380
Scientific Title The efficacy of High Flow Nasal Cannula Oxygen to prevent respiratory failure after extubation
Date of disclosure of the study information 2015/03/09
Last modified on 2015/07/12

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Basic information
Public title The efficacy of High Flow Nasal Cannula Oxygen to prevent respiratory failure after extubation
Acronym The efficacy of HFNC to prevent respiratory failure after extubation
Scientific Title The efficacy of High Flow Nasal Cannula Oxygen to prevent respiratory failure after extubation
Scientific Title:Acronym The efficacy of HFNC to prevent respiratory failure after extubation
Region
Japan

Condition
Condition respiratory failure after extubation
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To consider whether High Flow Nasal Cannula Oxygen is effective for the prevention of the respiratory failure after extubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes reintubation within 72 hours after extubation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients who receive oxygen through the HFNC after extubation
Interventions/Control_2 Patients who receive oxygen through the Ventury mask after extubation
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 1. 20 years of age or older
2. the risk of reintubation as follows: 65 years of olders, chronic heart failure, chronic respiratory disorders, Body mass index 30 or more, a PaO2/FiO2 less than or equal to 300 in spontaneous breathing trial
3.patients mechanically ventilated for more than 48 hours
4.patients successfully passed a spntaneous breathing trial(FiO2 0.4 or less, PEEP 5 or less)
Key exclusion criteria 1. under 20 years of age
2. a pregnant woman
3. tracheostomy
4. planned postextubation NPPV
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Isotani
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 2-1-1 Nisiogu, Arakawa-ku, Tokyo
TEL 03-3810-1111
Email isotaner@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takahashi
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 2-1-1 Nisiogu, Arakawa-ku, Tokyo
TEL 03-3810-1111
Homepage URL
Email htakahashi-tmd@umin.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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 03 Month 09 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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 03 Day
Last modified on
2015 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019380

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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