UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026467 |
|---|---|
| Receipt number | R000030368 |
| Scientific Title | An evaluation of CapnostreamTM for contribution to the safety in patients undergoing sedation for endoscopy |
| Date of disclosure of the study information | 2017/03/10 |
| Last modified on | 2018/03/09 13:05:45 |
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Basic information
Public title
An evaluation of CapnostreamTM for contribution to the safety in patients undergoing sedation for endoscopy
Acronym
The utility of CapnostreamTM in patients undergoing sedation for endoscopy
Scientific Title
An evaluation of CapnostreamTM for contribution to the safety in patients undergoing sedation for endoscopy
Scientific Title:Acronym
The utility of CapnostreamTM in patients undergoing sedation for endoscopy
Region
| Japan |
Condition
Condition
pancreatobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the utility of CapnostreamTM as a monitor for respiratory depression in patients undergoing sedation for pancreatobiliary endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Integrated pulmonary indexTM calculated with CapnostreamTM in patients undergoing sedation for pancreatobiliary endoscopy.
Key secondary outcomes
1.Comparison and association between Integrated pulmonary indexTM and oxygen saturation.
2.Comparison and association between Integrated pulmonary indexTM and end-tidal carbon dioxide.
3.Comparison and association between Integrated pulmonary indexTM and respiratory rate.
4.The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of Integrated pulmonary indexTM for respiratory depression.
5.Adverse events during this study.
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
1. Patients with the necessity of pancreatobiliary endoscopy
2.Patients who is American Society of Anesthesiologists physical status I-III
3. Patients who participated oneself with enough understanding after receiving enough explanation
Key exclusion criteria
1. Patients who is American Society of Anesthesiologists physical status 4 or 5
2. Patients who is unable to give informed consent
3. Patients required monitored anesthesia care sedation
4. Patients used oxygen or noninvasive ventilation devices before the procedure
5. patients who had allergies to midazolam
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Yamanishi |
Organization
Kinan Hospital
Division name
Gastroenterology
Zip code
Address
Shinjo-cho46-70, Tanabe, Wakayama
TEL
0739-22-5000
hiroyamanishi0925@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Yamanishi |
Organization
Kinan Hospital
Division name
Gastroenterology
Zip code
Address
Shinjo-cho46-70, Tanabe, Wakayama
TEL
0739-22-5000
Homepage URL
hiroyamanishi0925@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Kinan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
紀南病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2017 | Year | 03 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030368
