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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035108
Receipt No. R000039815
Official scientific title of the study Assessments of mask ventilation efficiency during anesthesia induction with using capnogram
Date of disclosure of the study information 2018/12/03
Last modified on 2018/12/02

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Basic information
Official scientific title of the study Assessments of mask ventilation efficiency during anesthesia induction with using capnogram
Title of the study (Brief title) 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 Shiroh Isono
Organization Chiba University
Division name Graduate School of Medicine, Anesthesiology
Address 1-8-1 Inohana Chuo Chiba
TEL 0432227171
Email shirohisono@yahoo.co.jp

Public contact
Name of contact person Taiichiro Hayashida
Organization Chiba University
Division name Graduate School of Medicine, Anesthesiology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 18 Day
Anticipated trial start date
2018 Year 12 Month 03 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 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
2018 Year 12 Month 02 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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