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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029967
Receipt No. R000034232
Scientific Title Usefulness of High-Flow Nasal Cannula for Prevention of Hypoxemia during bronchoscopy
Date of disclosure of the study information 2017/12/01
Last modified on 2017/11/14

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Basic information
Public title Usefulness of High-Flow Nasal Cannula for Prevention of Hypoxemia during bronchoscopy
Acronym Usefulness of High-Flow Nasal Cannula during bronchoscopy
Scientific Title Usefulness of High-Flow Nasal Cannula for Prevention of Hypoxemia during bronchoscopy
Scientific Title:Acronym Usefulness of High-Flow Nasal Cannula during bronchoscopy
Region
Japan

Condition
Condition mediastinal lymphadenopathy
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the usefulness of HFNC for prevention of hypoxemia during EBUS-TBNA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the lowest SpO2 during EBUS-TBNA
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 high-flow nasal cannula during EBUS-TBNA
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Adults with mediastinal or hilar lesions that were considered accessible by EBUS-TBNA
Key exclusion criteria Age >80 and <18 years; with acute respiratory or cardiovascular disease; with impaired oxygenation (SpO2 <95% at room air); regular use of benzodiazepine-related drugs; and dementia
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Takakuwa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Education and Research Center for Advanced Medicine
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8216
Email takakuwa@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Takakuwa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Education and Research Center for Advanced Medicine
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL 052-853-8216
Homepage URL
Email takakuwa@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization the Japanese Foundation for Research and Promotion of Endoscopy (JFE) Grant
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 12 Month 01 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
2014 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2015 Year 01 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
2017 Year 11 Month 14 Day
Last modified on
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034232

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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