UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024179 |
|---|---|
| Receipt number | 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 09:12:50 |
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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
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
sugino@ruby.ocn.ne.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.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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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
