UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028528
Receipt number R000022955
Scientific Title A Comparative Review of Airwayscope and Styletscope in case of CVCI
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/03 21:08:29

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Basic information

Public title

A Comparative Review of Airwayscope and Styletscope in case of CVCI

Acronym

A Comparative Review of Intubation devices in case of CSM

Scientific Title

A Comparative Review of Airwayscope and Styletscope in case of CVCI

Scientific Title:Acronym

A Comparative Review of Intubation devices in case of CSM

Region

Japan


Condition

Condition

cervical spondylotic myelopathy

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of the usefulness of the stylet scope

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The intubation time, and Change of vital signs, especially blood pressure, heart rate,and SpO2

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

We use an air way scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.

Interventions/Control_2

We use a stylet scope for tracheal intubation. We cancel a study three times when it is hard to intubate it even if it takes effect.

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

45 years-old <=

Age-upper limit

94 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients who receive a diagnosis of the cervical spondylotic myelopathy, and undergo cervical vertebrae laminoplasty

Key exclusion criteria

The patients who requried Subconscious fiber intubation, that an agreement was not obtained beforehand, are stage of more than ASA3

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name HIRANO HIROKO

Organization

CHUBU ROSAI Hospital

Division name

Anesthesiology

Zip code


Address

1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture

TEL

052-652-5511

Email

hrk0203ykng@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name HIRANO HIROKO

Organization

CHUBU ROSAI Hospital

Division name

Anesthesiology

Zip code


Address

1-10-6 Koumei Minatoku Nagoya City Aichi Prefecture

TEL

052-652-5511

Homepage URL


Email

hrk0203ykng@gmail.com


Sponsor or person

Institute

Anesthesiology of CHUBU ROSAI Hospital

Institute

Department

Personal name



Funding Source

Organization

no

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 08 Month 03 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

Open public recruiting

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2016 Year 04 Month 30 Day

Date of closure to data entry

2016 Year 04 Month 30 Day

Date trial data considered complete

2016 Year 05 Month 31 Day

Date analysis concluded

2016 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 03 Day

Last modified on

2017 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name