UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016872 |
|---|---|
| Receipt number | R000019584 |
| Scientific Title | Usefulness of High Flow Oxygen Therapy with Face Mask after minitracheostomy |
| Date of disclosure of the study information | 2015/03/23 |
| Last modified on | 2018/03/26 09:33:15 |
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Basic information
Public title
Usefulness of High Flow Oxygen Therapy with Face Mask after minitracheostomy
Acronym
Usefulness of high flow oxygen therapy with face mask
Scientific Title
Usefulness of High Flow Oxygen Therapy with Face Mask after minitracheostomy
Scientific Title:Acronym
Usefulness of high flow oxygen therapy with face mask
Region
| Japan |
Condition
Condition
Patients who inserted minitracheostomy after extubation
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to assess respiratory condition during high flow oxygen therapy via face mask.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is measurement of fraction of oxygen and positive end expiratory pressure via minitracheostomy during high flow oxygen therapy with face mask.
Key secondary outcomes
Respiratory parameter during high flow oxygen therapy with face mask will be compared to those with nasal high flow.
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
Patients who inserted minitracheostomy after extubation in intensive care unit.
Key exclusion criteria
Age under 18 years old and patients who have severe pulmonary comorbidity
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
045-787-2800
shunty5323@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shunsuke Takaki |
Organization
Yokohama City University
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
045-787-2800
Homepage URL
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Department of Anesthesiology
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 | 23 | 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
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cessation of research due to insufficient manpower
Management information
Registered date
| 2015 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019584
