UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015831
Receipt number R000018419
Scientific Title The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement
Date of disclosure of the study information 2014/12/04
Last modified on 2014/12/03 14:44:48

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Basic information

Public title

The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement

Acronym

The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement

Scientific Title

The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement

Scientific Title:Acronym

The evaluation of the King Vision TM, a novel video laryngoscope, in difficult airway model with restriction cervical spine movement

Region

Japan


Condition

Condition

intubation

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The evaluation of the King Vision TM in difficult airway model with restriction cervical spine movement

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intubation time

Key secondary outcomes

number of attempts, success rate of intubation, difficulty of the intubation attempts,cervical spine movement


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

intubation of the King Vision TM in difficult airway model with restriction cervical spine movement

Interventions/Control_2

intubation of the PENTAX Airway Scope in difficult airway model with restriction cervical spine movement

Interventions/Control_3

intubation of the Macintosh laryngoscope in difficult airway model with restriction cervical spine movement

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

ASA1-2
scheduled elective surgery
general anesthesia

Key exclusion criteria

emergency surgery
severe heart disease,
severe respiratory disease
gastroesophageal reflex disease
pregnancy
expected difficult l airway

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuki Akihisa

Organization

Mizonokuchi Hospital, Teikyo University School of Medicine

Division name

Anesthesiology

Zip code


Address

3-8-3Mizonokuchi, Takatsu, Kawasaki, Kanagawa

TEL

044-844-3333

Email

ypegtj25@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Akihisa

Organization

Mizonokuchi Hospital, Teikyo University School of Medicine

Division name

Anesthesiology

Zip code


Address

3-8-3Mizonokuchi, Takatsu, Kawasaki, Kanagawa

TEL

044-844-3333

Homepage URL


Email

ypegtj25@yahoo.co.jp


Sponsor or person

Institute

Mizonokuchi Hospital, Teikyo University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Teikyo University

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

2014 Year 12 Month 04 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

Preinitiation

Date of protocol fixation

2014 Year 12 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 04 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

2014 Year 12 Month 03 Day

Last modified on

2014 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name