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Recruitment status Completed
Unique ID issued by UMIN UMIN000012998
Receipt No. R000014373
Official scientific title of the study 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

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Basic information
Official scientific title of the study Assessment of end-tidal carbon dioxide for endoscopic screening or therapy using carbon dioxide
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Nobuaki Azemoto
Organization Ehime Prefectural Central Hospital
Division name Gastroenterology Center
Address Kasugamachi, Matsuyama, Ehime
TEL 089-947-1111
Email azemotonobu@gmmail.com

Public contact
Name of contact person Nobuaki Azemoto
Organization Ehime Prefectural Central Hospital
Division name Gastroenterology Center
Address Kasugamachi, Matsuyama, Ehime
TEL 089-947-1111
Homepage URL
Email azemotonobu@gmail.com

Sponsor
Institute Gastroenterology Center, Prefectural Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
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.
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014373


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