UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of High Flow Oxygen Therapy with Face Mask after minitracheostomy
Title of the study (Brief title)	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	Shunsuke Takaki
Organization	Yokohama City University
Division name	Intensive Care Unit
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2800
Email	shunty5323@gmail.com

Public contact
Name of contact person	shunsuke Takaki
Organization	Yokohama City University
Division name	Intensive Care Unit
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019584