UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026000
Receipt number R000029890
Scientific Title Examination of effectiveness of airway assessment method predicting difficulty of intubation
Date of disclosure of the study information 2017/02/28
Last modified on 2017/02/17 14:38:32

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Basic information

Public title

Examination of effectiveness of airway assessment method predicting difficulty of intubation

Acronym

Prediction of tracheal intubation difficulty levels

Scientific Title

Examination of effectiveness of airway assessment method predicting difficulty of intubation

Scientific Title:Acronym

Prediction of tracheal intubation difficulty levels

Region

Japan


Condition

Condition

Patients undergoing general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

There are many airway evaluation items at the bed side before surgery, but there is no item with high reliability that can predict intubation difficulties by itself.Therefore, we examined whether there was a high precision preoperative examination that could predict intubation difficulty more easily with a few preoperative examination items.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

After introduction of general anesthesia, laryngeal deployment was performed using the laryngoscope, and laryngeal findings were evaluated using Cormack-Lehane classification.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

16 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients scheduled to undergo general anesthesia

Key exclusion criteria

15 years old or younger, malformation of face / neck, pregnant woman

Target sample size

480


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshino Kazuhisa

Organization

Kitasato University School of Medicine

Division name

Anesthesiology

Zip code


Address

Kitasato 1-15-1 minamiku Sagamihara city Kanagawa

TEL

0427788111

Email

yoshinokazuhisa0906@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshino Kazuhisa

Organization

Kitasato University School of Medicine

Division name

Anesthesiology

Zip code


Address

Kitasato 1-15-1 minamiku Sagamihara city Kanagawa

TEL

0427788111

Homepage URL


Email

yoshinokazuhisa0906@yahoo.co.jp


Sponsor or person

Institute

Kitasato University School

Institute

Department

Personal name



Funding Source

Organization

none

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

2017 Year 02 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


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

2011 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 04 Day

Last modified on

2017 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name