UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in ventilation conditions by two kinds of face masks
Title of the study (Brief title)	Changes in ventilation conditions by two kinds of face masks
Region	Japan

Condition
Condition	Oral surgical operation under general anesthesia
Classification by specialty	Anesthesiology Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There are various kinds of ventilation masks, and regarding differences in the amount of evacuation by two kinds of general-purpose masks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Difference in ventilation after successful muscle relaxant
Key secondary outcomes

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	15 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Treatment plan under general anesthesia
Key exclusion criteria	Moderate or higher circulatory complications, respiratory complications Extremely mask ventilation difficulties
Target sample size	100

Research contact person
Name of lead principal investigator	Masanori Tsukamoto
Organization	Kyushu University Hospital
Division name	Department of Anesthesiology
Address	3-1-1 Higashidori Higashi ku Fukuoka city
TEL	092-6412-6480
Email	tsukamoto@dent.kyushu-u.ac.jp

Public contact
Name of contact person	Masanori Tsukamoto
Organization	Kyushu University Hospital
Division name	Department of Anesthesiology
Address	3-1-1 Higashidori Higashi ku Fukuoka city
TEL	092-6412-6480
Homepage URL
Email	tsukamoto@dent.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Kyushu University Hospital
Organization
Division
Category of Funding Organization	Other
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	2018 Year 09 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 05 Month 12 Day
Anticipated trial start date	2018 Year 05 Month 14 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	nothing

Management information
Registered date	2018 Year 09 Month 11 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038869