UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012998 |
|---|---|
| Receipt number | R000014373 |
| Scientific Title | Assessment of end-tidal carbon dioxide for endoscopic screening or therapy using carbon dioxide |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2017/02/02 17:32:55 |
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Basic information
Public title
Assessment of end-tidal carbon dioxide for endoscopic screening or therapy using carbon dioxide
Acronym
Assessment of end-tidal carbon dioxide for endoscopic screening or therapy using carbon dioxide
Scientific Title
Assessment of end-tidal carbon dioxide for endoscopic screening or therapy using carbon dioxide
Scientific Title:Acronym
Assessment of end-tidal carbon dioxide for endoscopic screening or therapy using carbon dioxide
Region
| Japan |
Condition
Condition
Patients with the necessity of receiving the routine endoscopic examination or endoscopic therapy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is assessment of the change of etCO2 before, under and after the routine endoscopic examination or endoscopic therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the change of etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
Key secondary outcomes
1. the change of arterial blood gas analysis before and after the routine endoscopic examination or endoscopic therapy
2. relationship between the respiratory function test and etCO2
3. relationship between arterial blood gas analysis and etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
4. relationship between age and etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
5. relationship between gender and etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
6. relationship between height, weight, body mass index and etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
7. relationship between past history, history of present illness, past herapy and etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
8. relationship between blood pressure and etCO2 before, under and after the routine endoscopic examination or endoscopic therapy
9. adverse event by 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 receiving the routine endoscopic examination or endoscopic therapy using CO2
2. Patients who participated oneself with enough understanding after receiving enough explanation
Key exclusion criteria
1. Patients who have PaO2<60mmHg or PaCO2>45mmHg before routine endoscopic examination or endoscopic therapy using CO2
2. Patients with the coagulation disorder
3. Patients who are judged inappropriate by principal investigator or sub-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuaki Azemoto |
Organization
Ehime Prefectural Central Hospital
Division name
Gastroenterology Center
Zip code
Address
Kasugamachi, Matsuyama, Ehime
TEL
089-947-1111
azemotonobu@gmmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Azemoto |
Organization
Ehime Prefectural Central Hospital
Division name
Gastroenterology Center
Zip code
Address
Kasugamachi, Matsuyama, Ehime
TEL
089-947-1111
Homepage URL
azemotonobu@gmail.com
Sponsor or person
Institute
Gastroenterology Center, Prefectural Central 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
愛媛県立中央病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 03 | 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
The use of CO2 was well tolerated in all patients without any adverse events.
The change of EtCO2 among before, under and after procedure was not significantly
PaCO2 after procedure was significantly higher than PaCO2 before procedure.
PaCO2 before procedure was significantly higher than EtCO2 before procedure. PaCO2 after procedure was also significantly higher than EtCO2 after procedure.
The change of EtCO2 was not significantly by respiratory functional test.
The change of EtCO2 was not significantly by gender.
The change of EtCO2 was not significantly by smoking history.
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 | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2017 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014373
