UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012338 |
|---|---|
| Receipt number | R000014426 |
| Scientific Title | The Effect of Tracheostomy Interface for High-Flow Oxygen Therapy to airway pressure in postoperative tracheostomy patients |
| Date of disclosure of the study information | 2013/11/18 |
| Last modified on | 2019/05/24 23:19:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
misumi@med.kobe-u.ac.jp
Public contact
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
misumi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014426
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
