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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029269
Receipt No. R000033454
Scientific Title Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Date of disclosure of the study information 2017/09/25
Last modified on 2019/06/10

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Basic information
Public title Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Acronym Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Scientific Title Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Scientific Title:Acronym Oxygen delivery to maintain the safeness of sedated patients during upper gastrointestinal endoscopy
Region
Japan

Condition
Condition
Gastrointestinal disease
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 evaluating oxygen delivery to maintain the safeness of sedated patients during nasal endoscopy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes transdermal oxygen saturation duaring endoscopy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 transnasal catheterization
Interventions/Control_2 cannula
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
18 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient who undergo endoscopy under sdation
Key exclusion criteria Patients who have permanent tracheostoma or serious respiratory tract, otolaryngology disorder
Target sample size 116

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Ishii
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code 1410022
Address 5-9-22 Higashigotanda Shinagawaku Tokyo
TEL 0334486111
Email meitokuso@yahoo.co.jp

Public contact
Name of contact person
1st name Ken
Middle name
Last name Ishii
Organization NTT Medical Center Tokyo
Division name Department of Gastroenterology
Zip code 1410022
Address 5-9-22 Higashigotanda Shinagawaku Tokyo
TEL 0334486111
Homepage URL
Email meitokuso@yahoo.co.jp

Sponsor
Institute NTT Medical Center Tokyo
Department of Gastroenterology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization NTT Medical Center Tokyo
Address 5-9-22 Higashigotanda Shinagawaku Tokyo
Tel 0334486111
Email meitokuso@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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 25 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 06 Month 21 Day
Anticipated trial start date
2017 Year 07 Month 01 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
2017 Year 09 Month 24 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033454

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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