UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of mask ventilation efficacy by pillow heightduring induction of general anesthesia
Title of the study (Brief title)	Comparison of mask ventilation efficacy by pillow heightduring
Region	Japan

Condition
Condition	Patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Ventilation efficacy assessment by pillow height.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ventilation volume at various PCV Intratracheal pressure at VCV
Key secondary outcomes	Subjective difficulty of mask ventilation

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 5cm pillow 2Mask ventilation with 15cm pillow
Interventions/Control_2	1Mask ventilation with 15cm pillow 2Mask ventilation with 5cm pillow
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 aneshtesia
Key exclusion criteria	emergency surgery difficult airway
Target sample size	20

Research contact person
Name of lead principal investigator	Toshiaki Minami
Organization	Osaka MedicalCollege
Division name	Anesgthesiology
Address	2-7 Daigaku-machi, Takatsuk city
TEL	072-696-2121
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	Department of Aneshesiology, 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 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 07 Day
Anticipated trial start date	2016 Year 03 Month 20 Day
Last follow-up date	2016 Year 04 Month 20 Day
Date of closure to data entry	2016 Year 04 Month 20 Day
Date trial data considered complete	2016 Year 04 Month 21 Day
Date analysis concluded	2016 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Ventilation volume was higher in high pillow trial than in low pillow trial.
Other related information	Subjective difficulty of mask ventilaton did not change significnatly.

Management information
Registered date	2016 Year 03 Month 17 Day
Last modified on	2016 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023910