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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025421
Receipt No. R000029245
Scientific Title Which is useful monitor for detecting apnea between respiratory sound and plethysmography in patients during ESD of gastrointestinal tract?
Date of disclosure of the study information 2016/12/28
Last modified on 2019/07/02

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Basic information
Public title Which is useful monitor for detecting apnea between respiratory sound and plethysmography in patients during ESD of gastrointestinal tract?
Acronym Which monitor is superior to detect apnea during ESD?
Scientific Title Which is useful monitor for detecting apnea between respiratory sound and plethysmography in patients during ESD of gastrointestinal tract?
Scientific Title:Acronym Which monitor is superior to detect apnea during ESD?
Region
Japan

Condition
Condition Patients who performed ESD of gastrointestinal tract.
Classification by specialty
Gastroenterology Gastrointestinal surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is useful to detect apnea promptly before desaturation due to respiratory depression or apnea when patients are performed ESD of gastrointestinal tract under sedation. The purpose of this study is to identify the best monitor to detect apnea promptly before desaturation when patients are performed ESD of lower gastrointestinal tract under sedation comparing with RR by ETCO2.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of alarm of showing SpO2 less than90%, Respiratory rate (RR) less than10 breathes per min or apnea
Key secondary outcomes 1. Differences of RR measuring by 3 monitors using respiratory sound, plethysmography and ETCO2
2. Changes of RR by sedatives
3. Differences of sensitivity of respiratory depression and apnea by 3 monitors
4. Depth of sedation

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 none
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Ozaki
Organization Tokyo Women's Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code 162-8666
Address 8-1 Kawada-cho Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email mozaki@anes.twmu.ac.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Fukada
Organization Tokyo Women's Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code 162-8666
Address 8-1 Kawada-cho Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email fukada.tomoko@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University, School of Medicine
Institute
Department

Funding Source
Organization Tokyo Women's Medical University, School of Medicine
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 Tokyo Women's Medical University, School of Medicine
Address 8-1 Kawada-cho Shinjuku-ku, Tokyo, Japan 1628666
Tel 0333538111
Email fukada.tomoko@twmu.ac.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
2016 Year 12 Month 28 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
2016 Year 04 Month 19 Day
Date of IRB
2019 Year 03 Month 18 Day
Anticipated trial start date
2017 Year 01 Month 05 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is the observation study for all patients who will be booked ESD of gastrointestinal tract.

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029245

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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