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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019697
Receipt No. 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

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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
Email 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
Email ysugimoto_0602@yahoo.co.jp

Sponsor
Institute JCHO Osaka Hopital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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