UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023019
Receipt number R000025003
Scientific Title Evaluation of head-rotation effect for mask ventilation in patients under general anesthesia.
Date of disclosure of the study information 2016/07/05
Last modified on 2016/08/31 07:39:52

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Basic information

Public title

Evaluation of head-rotation effect for mask ventilation in patients under general anesthesia.

Acronym

Mask ventilation efficacy by head rotation.

Scientific Title

Evaluation of head-rotation effect for mask ventilation in patients under general anesthesia.

Scientific Title:Acronym

Mask ventilation efficacy by head rotation.

Region

Japan


Condition

Condition

Patients who undergo general anesthesia

Classification by specialty

Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of head rotation effect for mask ventilation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mask ventilation profile

Key secondary outcomes

Subjective difficult of mask ventilation


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

Mask ventilation with head rotation to
Mask ventilation with normal status

Interventions/Control_2

Mask ventilation with normal status to
Mask ventilation with head rotation

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

75 years-old >=

Gender

Female

Key inclusion criteria

Patients who undergo general anesthesia

Key exclusion criteria

Patients with mask ventilation difficulty

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Minami

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7 Daigaku-machi, Takatsuk city

TEL

072-696-2121

Email

ane022@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyasu Komasawa

Organization

Osaka Medical College

Division name

Anesthesiology

Zip code


Address

2-7Daigaku-machi, Takatsuki city

TEL

0726-84-6361

Homepage URL


Email

ane078@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College

Institute

Department

Personal name



Funding Source

Organization

Osake Medical College

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 07 Month 05 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

Mask ventilation volume did not differ significantly by head rotation.

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

2016 Year 07 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 10 Day

Last follow-up date

2016 Year 08 Month 30 Day

Date of closure to data entry

2016 Year 08 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjective difficulty of mask ventilation by anesthesiologists did not differ significnatly.


Management information

Registered date

2016 Year 07 Month 04 Day

Last modified on

2016 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025003


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name