UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An evaluation of CapnostreamTM for contribution to the safety in patients undergoing sedation for endoscopy
Title of the study (Brief title)	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	Hirofumi Yamanishi
Organization	Kinan Hospital
Division name	Gastroenterology
Address	Shinjo-cho46-70, Tanabe, Wakayama
TEL	0739-22-5000
Email	hiroyamanishi0925@gmail.com

Public contact
Name of contact person	Hirofumi Yamanishi
Organization	Kinan Hospital
Division name	Gastroenterology
Address	Shinjo-cho46-70, Tanabe, Wakayama
TEL	0739-22-5000
Homepage URL
Email	hiroyamanishi0925@gmail.com

Sponsor
Institute	Department of Gastroenterology, Kinan 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	紀南病院（和歌山県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030368