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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016872
Receipt No. 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

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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
Email 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
Email shunty5323@gmail.com

Sponsor
Institute Yokohama City University Department of Anesthesiology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019584

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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