UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023506
Receipt number R000026994
Scientific Title The usefulness of the video laryngoscope for nasotracheal intubation
Date of disclosure of the study information 2016/08/05
Last modified on 2019/05/11 09:39:38

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Basic information

Public title

The usefulness of the video laryngoscope for nasotracheal intubation

Acronym

The usefulness of the video laryngoscope for nasotracheal intubation

Scientific Title

The usefulness of the video laryngoscope for nasotracheal intubation

Scientific Title:Acronym

The usefulness of the video laryngoscope for nasotracheal intubation

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Anesthesiology Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the usefulness of
video laryngoscope for nasotracheal intubation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)Intubation time
2)Quality of view
3)Ease of blade insertion

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Interventions of this study is to use video laryngoscope
(Mac glass) for nasotracheal intubation.

Interventions/Control_2

Interventions of this study is to use video laryngoscope
(Airway scope) for nasotracheal intubation.

Interventions/Control_3

Interventions of this study is to use Macintosh
laryngoscope for nasotracheal intubation.

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

Healthy Adults

Key exclusion criteria

The key exclusion criteria is as follows.
Patients who are expected to have a difficulty of tracheal
intubation before an intervention.

Target sample size

51


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Harada

Organization

Aichi Gakuin University
School of Dentistry

Division name

Department of Anesthesiology

Zip code


Address

2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan

TEL

052-759-2111

Email

hjun@dpc.agu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Aiji Boku

Organization

Aichi Gakuin University School of Dentistry

Division name

Department of Anesthesiology

Zip code


Address

2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan

TEL

052-759-2111

Homepage URL


Email

bokuaiji@dpc.aichi-gakuin.ac.jp


Sponsor or person

Institute

Aichigakuin University, School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Aichigakuin University, School of Dentistry

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

愛知学院大学歯学部附属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 05 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

Tracheal intubation time was 27.0, 6.0 seconds (average, standard deviation) for the McG group, 38.0,12.0 seconds for the AWS group, and 36.0 , 10.0 seconds for the Macintosh group, indicating significantly shorter tracheal intubation time in the McG group than in the AWS group (p < 0.01) and the Macintosh group (p <0.05). Cormack Lehane grade was significantly improved in the M group compared to the N group (p< 0.05).

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

Main results already published

Date of protocol fixation

2016 Year 07 Month 15 Day

Date of IRB

2016 Year 07 Month 06 Day

Anticipated trial start date

2016 Year 08 Month 08 Day

Last follow-up date

2016 Year 12 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 05 Day

Last modified on

2019 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026994


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name