UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036269 |
|---|---|
| Receipt number | R000041234 |
| 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 |
| Date of disclosure of the study information | 2019/03/23 |
| Last modified on | 2022/03/23 21:24:20 |
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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
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
nhosoe@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041234
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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