UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021507
Receipt number R000023910
Scientific Title Comparison of mask ventilation efficacy by pillow heightduring induction of general anesthesia
Date of disclosure of the study information 2016/03/17
Last modified on 2016/04/20 09:12:13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of mask ventilation efficacy by pillow heightduring induction of general anesthesia

Acronym

Comparison of mask ventilation efficacy by pillow heightduring

Scientific Title

Comparison of mask ventilation efficacy by pillow heightduring induction of general anesthesia

Scientific Title:Acronym

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


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



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

1st name
Middle name
Last name Toshiaki Minami

Organization

Osaka MedicalCollege

Division name

Anesgthesiology

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

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)



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 03 Month 17 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

Ventilation volume was higher in high pillow trial than in low pillow trial.

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 03 Month 07 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023910


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name