UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019697 |
|---|---|
| Receipt number | R000022754 |
| Scientific Title | The assessment of the efficacy of Nasal High Flow System during sedation for the operation |
| Date of disclosure of the study information | 2015/11/10 |
| Last modified on | 2020/05/14 22:58:51 |
* 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 assessment of the efficacy of Nasal High Flow System during sedation for the operation
Acronym
The efficacy of Nasal High Flow System during sedation for the operation
Scientific Title
The assessment of the efficacy of Nasal High Flow System during sedation for the operation
Scientific Title:Acronym
The efficacy of Nasal High Flow System during sedation for the operation
Region
| Japan |
Condition
Condition
patients who are sedated during the operation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Nasal High Flow System on the patients who are sedated during the operation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To assess the betterment of general or resperational state (apnea hypopnea index,oxygen saturation,body motion etc.)before and after the usage of Nasal High Flow System. We assess at the end of the usage of Nasal High Flow System.
Key secondary outcomes
To assess whether patients feel any inconvinience or not at the end of the operation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We use Nasal High Flow System in case which the respirational state becomes worse because of the sadation during the operation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients whose state of respiration becomes worse because of the sadation during the operation
patients who are able to provide written informed consent
Key exclusion criteria
patients who are judged inappropriate by the researchers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Beppu |
Organization
JCHO Osaka Hospital
Division name
Department of Anesthesia
Zip code
553-0003
Address
4-2-78 Fukushima, Fukushima-ku,Osaka city
TEL
06-6441-5451
ysugimoto_0602@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Beppu |
Organization
JCHO Osaka Hospital
Division name
Department of Anesthesia
Zip code
553-0003
Address
4-2-78 Fukushima, Fukushima-ku,Osaka city
TEL
06-6441-5451
Homepage URL
ysugimoto_0602@yahoo.co.jp
Sponsor or person
Institute
JCHO Osaka Hopital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCHO Osaka Hospital
Address
4-2-78 Fukushima, Fukushima-ku,Osaka city
Tel
06-6441-5451
ysugimoto_0602@yahoo.co.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
JCHO大阪病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 10 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2005 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022754
