UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Tracheostomy Interface for High-Flow Oxygen Therapy to airway pressure in postoperative tracheostomy patients
Acronym	The Effect of OptiflowTM Tracheostomy Interface to airway pressure in postoperative tracheostomy patients
Scientific Title	The Effect of Tracheostomy Interface for High-Flow Oxygen Therapy to airway pressure in postoperative tracheostomy patients
Scientific Title:Acronym	The Effect of OptiflowTM Tracheostomy Interface to airway pressure in postoperative tracheostomy patients
Region	Japan

Condition
Condition	postoperative tracheostomy patient
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	High-flow oxygen therapy tracheotomy connector made by Fisher&Paykel company is used with postoperative tracheotomy patients, and effect of airway pressure changes on PEEP and ventilation assistance which is regulated by the position of attached cap is analyzed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	work of breathing
Key secondary outcomes	vital sign Oxygenation comfort

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	7
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	trachmask gas flow 40L/min
Interventions/Control_2	tracheotomy connector position of cap: regular gas flow 20L/min
Interventions/Control_3	tracheotomy connector position of cap: low gas flow 20L/min
Interventions/Control_4	tracheotomy connector position of cap: regular gas flow 40L/min
Interventions/Control_5	tracheotomy connector position of cap: low gas flow 40L/min
Interventions/Control_6	tracheotomy connector position of cap: regular gas flow 60L/min
Interventions/Control_7	tracheotomy connector position of cap: low gas flow 60L/min
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age: 20 years old and older at the time of written consent 2. Sex: no matter 3. Hospitalization, Severity: All of the postoperative patients in ICU who can communicate 4. Disease, Patient Condition: All of the postoperative patients who needs tracheotomy for several diseases or causes, and must be kept on spontaneous breathing but require oxygen therapy 5. Disease duration: no matter 6. All the patients who can provide the documented consent for the participation of this study before the start of final research
Key exclusion criteria	1. Unstable patients in circulation and respiratory 2. The patients who needs ventilation management 3. The patients who cannot communicate 4. The patients who will suffer from this study
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Takuyo Middle name Last name Misumi
Organization	Kobe University Hospital
Division name	Department of Intensive Care Medicine
Zip code	650-0017
Address	7-5-2,Kusunoki-cho,chuo-ku,kobe,Hyogo, 650-0017,Japan
TEL	078-382-5111
Email	misumi@med.kobe-u.ac.jp

Public contact
1st name of contact person	1st name Misumi Middle name Last name Takuyo Misumi
Organization	Kobe University Hospital
Division name	Department of Intensive Care Medicine
Zip code	650-0017
Address	7-5-2,Kusunoki-cho,chuo-ku,kobe,Hyogo, 650-0017,Japan
TEL	078-382-5111
Homepage URL
Email	misumi@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University Hospital
Address	7-5-2,Kusunoki-cho,chuo-ku,kobe,Hyogo, 650-0017,Japan
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

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	神戸大学医学部附属病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 18 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	Completed
Date of protocol fixation	2013 Year 11 Month 18 Day
Date of IRB	2013 Year 11 Month 18 Day
Anticipated trial start date	2013 Year 11 Month 18 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 18 Day
Last modified on	2019 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014426