UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of mask ventilation efficacy by cricoid pressure
Title of the study (Brief title)	Mask ventilation efficacy bt cricoid pressure.
Region	Japan

Condition
Condition	Patients undergoing general anesthesia with rapid induction.
Classification by specialty	Anesthesiology Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating the mask ventilation efficacy by cricoid pressure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mask ventilation efficacy for ventilation volume or intratracheal pressure
Key secondary outcomes	Subhective difficult of anesthesiologists

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1Mask ventilation with cricoid pressure 2Mask Ventilation without cricoid pressure
Interventions/Control_2	1Mask Ventilation without cricoid pressure 2Mask ventilation with cricoid pressure
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing general anesthesia with rapid induction.
Key exclusion criteria	Patients with anticipated mask ventilation difficulty or GER.
Target sample size	20

Research contact person
Name of lead principal investigator	Toshiaki Minami
Organization	Osaka Medical College
Division name	Anesgthesiology
Address	2-7 Daigaku-machi, Takatsuk city
TEL	0726-84-6361
Email	ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person	Nobuyasu Komasawa
Organization	Osaka Medical College
Division name	Anesthesiology
Address	2-7Daigaku-machi, Takatsuki city
TEL	0726-84-6361
Homepage URL
Email	ane078@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
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 05 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 02 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2016 Year 06 Month 20 Day
Date of closure to data entry	2016 Year 06 Month 21 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Ventilation volume by pressure controlled ventilation was reduced by cricoid pressure at 10, 15, 20 cmH2O.
Other related information	Subjective difficuty of manual ventilation did not significantly differ.

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2016 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024919