UMIN-CTR Clinical Trial

Basic information
Public title	Study on bronchoscopy when using an endoscopic mask
Acronym	endoscopic mask
Scientific Title	Study on bronchoscopy when using an endoscopic mask
Scientific Title:Acronym	endoscopic mask
Region	Japan

Condition
Condition	Patients who undergo bronchoscopy
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on the operation of the endoscope and the effect on the patient by wearing the newly developed mask for the endoscope during bronchoscopy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence rate of decreased oxygen saturation (SpO2 <90%) during inspection
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Put on an endoscopic mask and have a bronchoscopy.
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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients over 15 years old Patients who undergo bronchoscopy for diagnosis of respiratory diseases at our hospital Patients with sufficient respiratory function to undergo bronchoscopy. Specifically, patients with normal respiratory function or stage 1 COPD. Patients with 90% or more of resting SpO2 (room air).Patients who understand the research content and have written informed consent.
Key exclusion criteria	Patients who are unable to stay at rest during bronchoscopy. Patients with a history of CO2 narcosis. Patients without consent
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shotaro Middle name Last name Okachi
Organization	Nagoya university hospital
Division name	Respirology
Zip code	466-8560
Address	65-Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2167
Email	s.okachi@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Shotaro Middle name Last name Okachi
Organization	Nagoya University hospital
Division name	Respirology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2167
Homepage URL
Email	s.okachi@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Nagoya university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University School Medicine Bioethics Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2111
Email	ethics@med.nagoya-u.ac.jp.

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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 28 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
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	Enrolling by invitation
Date of protocol fixation	2020 Year 10 Month 21 Day
Date of IRB	2020 Year 11 Month 02 Day
Anticipated trial start date	2020 Year 11 Month 04 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 18 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047398