UMIN-CTR Clinical Trial

Basic information
Public title	Assessments of mask ventilation efficiency during anesthesia induction with using capnogram
Acronym	Assessments of mask ventilation efficiency with using capnogram
Scientific Title	Assessments of mask ventilation efficiency during anesthesia induction with using capnogram
Scientific Title:Acronym	Assessments of mask ventilation efficiency with using capnogram
Region	Japan

Condition
Condition	patient under going general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We test a hypothesis that the value of end-tidal carbon dioxide concentration predicts tidal volume achieved by mask ventilation during anesthesia induction when the phase II capnogram waveform is only detected.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	End tidal carbon dioxide concentration
Key secondary outcomes	tidal volume, back ground parameters, results of preoperative sleep study, and respiratory variables during mask ventilation

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	Patients scheduled to undergo general anesthesia
Key exclusion criteria	1) Planned intubation with consciousness 2) Full Stomac 3) Patients who have a fistula in the respiratory tract such as tracheostomy and tracheoesophageal fistula 4) Emergency operation 5)Allergy to drugs scheduled for use 6) Patients who have dementia
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shiroh Middle name Last name Isono
Organization	Chiba University
Division name	Graduate School of Medicine, Anesthesiology
Zip code	260-8677
Address	1-8-1 Inohana Chuo Chiba
TEL	0432227171
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	1st name Taiichiro Middle name Last name Hayashida
Organization	Chiba University
Division name	Graduate School of Medicine, Anesthesiology
Zip code	260-8677
Address	1-8-1 Inohana Chuo Chiba
TEL	0432227171
Homepage URL
Email	anpapal.71@gmail.com

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	None
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	Chiba University Hospital
Address	1-8-1 Inohana Chuo Chiba
Tel	0432227171
Email	chibacrc@mac.com

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 12 Month 03 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	Completed
Date of protocol fixation	2018 Year 10 Month 18 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 12 Month 03 Day
Last follow-up date	2020 Year 01 Month 22 Day
Date of closure to data entry	2020 Year 01 Month 23 Day
Date trial data considered complete	2020 Year 10 Month 10 Day
Date analysis concluded	2020 Year 11 Month 30 Day

Other
Other related information	Capnogram waveform, end-tidal carbon dioxide concentration, and tidal volume during mask ventilation during planned anesthesia induction are continuously measured with using patient monitoring system. The composite video images of the patient monitor display and the video camera image of the anesthesiologist are continuously recorded during anesthesia induction and used for later data analyses.

Management information
Registered date	2018 Year 12 Month 02 Day
Last modified on	2020 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039815