UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016699 |
|---|---|
| Receipt number | 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 21:05:00 |
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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
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
htakahashi-tmd@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019380
