UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033181
Receipt number R000037747
Scientific Title The effect of the head-up position on mask ventilation during induction of general anesthesia
Date of disclosure of the study information 2018/07/01
Last modified on 2021/07/01 12:08:26

* 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

The effect of the head-up position on mask ventilation during induction of general anesthesia

Acronym

The effect of the head-up position on mask ventilation during induction of general anesthesia

Scientific Title

The effect of the head-up position on mask ventilation during induction of general anesthesia

Scientific Title:Acronym

The effect of the head-up position on mask ventilation during induction of general anesthesia

Region

Japan


Condition

Condition

Patients scheduled for surgeries under general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of head-up position on mask ventilation in induction of general anesthesia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The amount of ventilation on mask ventilation in induction of general anesthesia

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is 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

on mask ventilation

Interventions/Control_2

on mask ventilation

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

55 years-old >

Gender

Male and Female

Key inclusion criteria

Patients scheduled for surgeries under general anesthesia

Key exclusion criteria

Edentulous patients, patients with full stomach, patients with severe co-morbidities, and patients with allergy for rocronium or propofol are excluded.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ayano Tai

Organization

Toyooka hospital

Division name

Department of Anesthesiology

Zip code


Address

1094, Tobera, Toyooka-shi, Hyogo

TEL

0796226111

Email

amssisters@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ayano Tai

Organization

Toyooka hospital

Division name

Department of Anesthesiology

Zip code


Address

1094, Tobera, Toyooka-shi, Hyogo

TEL

0796226111

Homepage URL


Email

amssisters@yahoo.co.jp


Sponsor or person

Institute

Toyooka hospital

Institute

Department

Personal name



Funding Source

Organization

Toyooka hospital

Organization

Division

Category of Funding Organization

Other

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

2018 Year 07 Month 01 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


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

2018 Year 07 Month 01 Day

Date of IRB

2018 Year 06 Month 20 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 06 Month 28 Day

Last modified on

2021 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037747


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name