UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018488
Receipt number R000020461
Scientific Title Evaluation of intubation efficacy evaluation with or without stylet
Date of disclosure of the study information 2015/07/31
Last modified on 2016/05/11 21:53:32

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Basic information

Public title

Evaluation of intubation efficacy evaluation with or without stylet

Acronym

Intubation efficacy evaluation with or without stylet

Scientific Title

Evaluation of intubation efficacy evaluation with or without stylet

Scientific Title:Acronym

Intubation efficacy evaluation with or without stylet

Region

Japan


Condition

Condition

Patient who undergo general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of stylet for tracehal intubation

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intubation time
times of laryngoscopy
progression time

Key secondary outcomes

Patient characteristics


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Device,equipment

Interventions/Control_1

Tracehal intubation with stylet

Interventions/Control_2

Tracheal intubation without stylet

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patient who undergo general anesthesia

Key exclusion criteria

Crash induction
Prone
DLT

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyasu Komasawa

Organization

Osaka Medical College

Division name

Anesgthesiology

Zip code


Address

2-7 Daigaku-machi, Takatsuk city

TEL

0726-84-6361

Email

ane078@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Komasawa Nobuyasu

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

Hokusetsu General Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokusetsu General Hospital

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

2015 Year 07 Month 31 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

Pharyngeal pain was significantly higher in the stylet group than in the control group.

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

2015 Year 05 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 31 Day

Last follow-up date

2016 Year 05 Month 10 Day

Date of closure to data entry

2016 Year 05 Month 12 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

There were no sigifnicant difference between the stylet and non-stylet group about the incidence of postoperative hoarseness.


Management information

Registered date

2015 Year 07 Month 30 Day

Last modified on

2016 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name