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

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 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


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

Value
https://center6.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