UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008778 |
|---|---|
| Receipt number | R000010317 |
| Scientific Title | Evaluation of Nasal High Flow Oxygen Therapy for Severe Acute Hypoxemic Respiratory Failure. |
| Date of disclosure of the study information | 2012/08/27 |
| Last modified on | 2015/05/21 13:07:19 |
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Basic information
Public title
Evaluation of Nasal High Flow Oxygen Therapy for Severe Acute Hypoxemic Respiratory Failure.
Acronym
Evaluation of Nasal High Flow Oxygen Therapy.
Scientific Title
Evaluation of Nasal High Flow Oxygen Therapy for Severe Acute Hypoxemic Respiratory Failure.
Scientific Title:Acronym
Evaluation of Nasal High Flow Oxygen Therapy.
Region
| Japan |
Condition
Condition
Severe acute hypoxemic respiratory failure
Classification by specialty
| Pneumology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effects of Nasal High Flow Oxygen Therapy and Non Invasive Ventilation in severe acute hypoxemic respiratory failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interface discomfort
Key secondary outcomes
dyspnea
easy to speak, sleep perception, easy to eat and drink
arterial blood gas analysis
vital signs
early failure
length of ICU stay
length of hospital stay
in-hospital mortality
90-day survival
complications
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
Nasal High Flow Oxygen Therapy
Interventions/Control_2
Non Invasive Ventilation
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.admitted to respiratory department of our hospital for severe acute hypoxemic respiratory failure(AHRF) other than cardiogenic pulmonary edema
2.met the standard clinical and/or blood gas criteria for use of NIV to treat severe AHRF
3.have received NIV for less than 12 hours
Key exclusion criteria
1.hypercapnia (PaCO2>45mmHg)
2.unstable clinical conditions (i.e., need for vasopressors, metabolic acidosis, life-threatening arrhythmias, need for FiO2>=0.8, agitation and anxiety
3.inability to obtain consent
4.face or neck deformities
5.use of NIV before admission
6.need for continuous sedation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Tomii |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuma Nagata |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-1 Minatojima-minamimachi, Chuo-ku, Kobe
TEL
Homepage URL
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | 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
| 2012 | Year | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010317
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
