UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pattern and route of breathing during endoscopic therapy under sedation
Title of the study (Brief title)	Breathing during endoscopy under sedation
Region	Japan

Condition
Condition	Adults undergoing endoscopic therapy under sedation
Classification by specialty	Gastroenterology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore usefulness of the nasal pressure measurement for detecting breathing abnormalities and route of breathing in adult patients undergoing endoscopic therapy under sedation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	time spent for oral breathing during endoscopic therapy
Key secondary outcomes	frequency of breathing abnormalities, respiratory rate, 3% oxygen desaturation index, patient background

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	Adult patients undergoing endoscopic therapy under sedation
Key exclusion criteria	1) patients who need tracheal intubation during the endoscopy 2) patients under oxygen therapy before the procedure 3) patients with unstable hymodynamics
Target sample size	20

Research contact person
Name of lead principal investigator	Shiroh Isono
Organization	Chiba University
Division name	Department of Anesthesiology, Graduate School of Medicine,
Address	1-8-1 Inohana-cho, Chuo-ku
TEL	+81432262155
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Chiba University
Division name	Department of Anesthesiology, Graduate School of Medicine
Address	1-8-1 Inohana-cho, Chuo-ku
TEL	043-222-7171
Homepage URL
Email	shirohisono@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Nihon Kohden Inc.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 28 Day
Anticipated trial start date	2016 Year 08 Month 31 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	Unpublished
URL releasing results
Results
Other related information	This is a prospective observation study exploring frequency and types of abnormal breathing and predominant route of breathing in 20 adult patients undergoing endoscopic therapy under sedation. 10 immediate-postoperative patients will be also invited as a reference of the breathing after sedation. In order to determine analytic plan for the prospective study, retrospective data analyses of patients who underwent the endoscopic therapy between 2014 and July 2016 will be performed.

Management information
Registered date	2016 Year 08 Month 30 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027469