UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement
Acronym	Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement
Scientific Title	Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement
Scientific Title:Acronym	Exploratory study about risk factors of respiratory complications in invasive trans oral with combined use of exhaled CO2 concentration measurement and patient awakening measurement
Region	Japan

Condition
Condition	Upper gastrointestinal bleeding/tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to assess risk factors for respiratory complications that occur during invasive trans-oral endoscopy (endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR), gastrostomy, oral enteroscopy, endoscopic hemostasis procedure) by monitor CO2 concentration in exhaled breath and awakening level by BIS monitor.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hypoxemia (SpO2 <90% lasts more than 15 seconds)
Key secondary outcomes	Apnea (exhaled CO2 detection continues for more than 15 seconds),Vital abnormality(Hypotension (systolic blood pressure 90 mmHg or less lasts more than 1 minute), Bradycardia (50 pulses per minute or less lasting more than 1 minute)), Type of examination, Procedure related items (examination time, total sedative dose, total oxygen dose),Severe hypoxemia (SpO2 <85% lasts more than 15 seconds), Serious complications (pneumonia requiring oxygen administration, bleeding requiring blood transfusion, perforation of digestive tract etc.), Patient satisfaction (Numerical Rating Scale (NRS) 10 stages (questioned by nurse in recovery room after examination), cooperation of patients by implementation doctor evaluation (NRS 10 grade)

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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who receive upper treatment endoscope, and provided informed consent for this study.
Key exclusion criteria	Patients who disagree with this study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Hosoe
Organization	Keio University School of Medicine
Division name	Center for Diagnostic and Therapeutic Endoscopy
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3760
Email	nhosoe@keio.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Hosoe
Organization	Keio University School of Medicine
Division name	Center for Diagnostic and Therapeutic Endoscopy
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3760
Homepage URL
Email	nhosoe@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
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	Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-5363-3760
Email	med-rinri-jimu@adst.keio.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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 23 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	2018 Year 10 Month 06 Day
Date of IRB	2019 Year 03 Month 23 Day
Anticipated trial start date	2019 Year 03 Month 23 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	non

Management information
Registered date	2019 Year 03 Month 21 Day
Last modified on	2022 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041234