UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013254
Receipt number R000015462
Scientific Title Endotrol-tracheal tube assisted endotracheal intubation during McGrathR
Date of disclosure of the study information 2014/02/25
Last modified on 2015/03/06 06:09:24

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Basic information

Public title

Endotrol-tracheal tube assisted endotracheal intubation during McGrathR

Acronym

Endotrol-tracheal tube assisted endotracheal intubation during McGrathR

Scientific Title

Endotrol-tracheal tube assisted endotracheal intubation during McGrathR

Scientific Title:Acronym

Endotrol-tracheal tube assisted endotracheal intubation during McGrathR

Region

Japan


Condition

Condition

cases of general anesthesia

Classification by specialty

Anesthesiology Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the ways the tracheal tube was intubated safely and quickly

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intubation time

Key secondary outcomes

intubation number
postoperative hoarseness and sore throat
cormack classification


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Normal tracheal tubu assisted endotracheal intubation during Macintosh laryngoscope

Interventions/Control_2

Endotrol-tracheal tube assisted endotracheal intubation during McGrathR

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

cases of general anesthesia

Key exclusion criteria

cases of difficult airway
the patients refused consent

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hronobu Ueshima

Organization

Saitama Medical University International Medical Center

Division name

Anesthesiology

Zip code


Address

1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan.

TEL

818031320591

Email

ueshimhi@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironobu Ueshima

Organization

Saitama Medical University International Medical Center

Division name

Anesthesiology

Zip code


Address

1397-1 Yamane, Hidaka City, Saitama, 350-1298, Japan.

TEL

818031320591

Homepage URL


Email

ueshimhi@yahoo.co.jp


Sponsor or person

Institute

Saitama Medical University International Medical Center

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

2014 Year 02 Month 25 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

2013 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 25 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 02 Month 25 Day

Last modified on

2015 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015462


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name