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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023846
Receipt No. R000027469
Scientific Title Pattern and route of breathing during endoscopic therapy under sedation
Date of disclosure of the study information 2016/08/30
Last modified on 2018/05/31

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Basic information
Public title Pattern and route of breathing during endoscopic therapy under sedation
Acronym Breathing during endoscopy under sedation
Scientific Title Pattern and route of breathing during endoscopic therapy under sedation
Scientific Title:Acronym Breathing during endoscopy under sedation
Region
Japan

Condition
Condition Adults undergoing endoscopic therapy under sedation
Classification by specialty
Gastroenterology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore usefulness of the nasal pressure measurement for detecting breathing abnormalities and route of breathing in adult patients undergoing endoscopic therapy under sedation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes time spent for oral breathing during endoscopic therapy
Key secondary outcomes frequency of breathing abnormalities, respiratory rate, 3% oxygen desaturation index, patient background

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients undergoing endoscopic therapy under sedation
Key exclusion criteria 1) patients who need tracheal intubation during the endoscopy
2) patients under oxygen therapy before the procedure
3) patients with unstable hymodynamics
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiroh Isono
Organization Chiba University
Division name Department of Anesthesiology, Graduate School of Medicine,
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku
TEL +81432262155
Email shirohisono@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiroh Isono
Organization Chiba University
Division name Department of Anesthesiology, Graduate School of Medicine
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku
TEL 043-222-7171
Homepage URL
Email shirohisono@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Nihon Kohden Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 08 Month 30 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
2016 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observation study exploring frequency and types of abnormal breathing and predominant route of breathing in 20 adult patients undergoing endoscopic therapy under sedation. 10 immediate-postoperative patients will be also invited as a reference of the breathing after sedation. In order to determine analytic plan for the prospective study, retrospective data analyses of patients who underwent the endoscopic therapy between 2014 and July 2016 will be performed.

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027469

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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