UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010644
Receipt number R000012443
Scientific Title Comparison of usefulness of Airway scope guided nasotracheal intubation with conventional Macintosh laryngoscope in clinical study
Date of disclosure of the study information 2013/05/07
Last modified on 2015/05/13 09:15:07

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Basic information

Public title

Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study

Acronym

Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study

Scientific Title

Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study

Scientific Title:Acronym

Comparison of usefulness of Airway scope guided nasotracheal intubation
with conventional Macintosh laryngoscope in clinical study

Region

Japan


Condition

Condition

oral surgery

Classification by specialty

Anesthesiology Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the usefulness of Airway scope during nasotracheal intubation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the time to nasotracheal intubation, the number of nasotracheal intubation, hemodynamic change during nasotracheal intubation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Machintosh laryngoscope

Interventions/Control_2

Airway scope

Interventions/Control_3

McGRATH-MAC

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

the patients with ASA physical status 1 and 2, aged 20 to 80 years old, who were scheduled to undergo oral surgery and general anesthesia by nasotracheal intubation

Key exclusion criteria

the patients who rejected for the administration of the study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsutaka Edanaga

Organization

Sapporo Medical University School of Medicine

Division name

Department of anesthesiology

Zip code


Address

South-1 West-16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

edanaka@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsutaka Edanaga

Organization

Sapporo Medical University School of Medicine

Division name

Department of anesthesiology

Zip code


Address

South 1, East 16, chuoku, Sapporo

TEL

011-611-2111

Homepage URL


Email

edanaka@sapmed.ac.jp


Sponsor or person

Institute

Department of Anesthesiology, Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Sapporo Medical University School of Medicine

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

2013 Year 05 Month 07 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

Terminated

Date of protocol fixation

2012 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 02 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

2013 Year 05 Month 03 Day

Last modified on

2015 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012443


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name