UMIN-CTR Clinical Trial

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

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	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

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/icdr_e/ctr_view.cgi?recptno=R000014373