UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032544
Receipt number R000035025
Scientific Title The efficacy of video laryngoscope on visualization of larynx in intubated patients
Date of disclosure of the study information 2018/05/10
Last modified on 2019/11/21 13:59:49

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Basic information

Public title

The efficacy of video laryngoscope on visualization of larynx in intubated patients

Acronym

The efficacy of video laryngoscope in intubated patients

Scientific Title

The efficacy of video laryngoscope on visualization of larynx in intubated patients

Scientific Title:Acronym

The efficacy of video laryngoscope in intubated patients

Region

Japan


Condition

Condition

Efficacy of video-laryngoscope on visualization of airway anatomy in tracheal intubated patients

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Visualization of airway anatomy and manipulation facilitates tracheal tube exchange, nasogastric tube insertion and transesophageal echocardiography probe insertion. In intubated patients, classical Macintosh laryngoscope (Macintosh) is sometimes difficult to visualize airway anatomy. Video-laryngoscopes are known to provide better view of airway anatomy than Macintosh dose. However, efficacy of video-laryngoscope as an aid to visualize airway anatomy in intubated patients has not been evaluated. Thus, we evaluate the efficacy of two video-laryngoscopes; McGRATH MAC (McGRATH) and Airway Scope (AWS) as an aid for visualization of larynx in intubated patients compared with Macintosh.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of difficult airway anatomy visualization

Key secondary outcomes

Cormack-Lehane Grade


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent elective surgery and scheduled to admit ICU

Key exclusion criteria

Patients underwent neck surgery
Patients with oropharyngeal infection or neck pain.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Ishida

Organization

Shinshu University of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2670

Email

tisd@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Ishida

Organization

Shinshu University of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

3908621

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2670

Homepage URL


Email

tisd@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Shinshu University of Medicine Department of Anesthesiology and Resuscitology

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

Ethical committee of Shinshu University of Medicine

Address

3-1-1 Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

3677

Org. issuing International ID_1

Ethical committee of Shinshu University of Medicine

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 10 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

20

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

2018 Year 05 Month 10 Day

Date of IRB

2017 Year 04 Month 04 Day

Anticipated trial start date

2018 Year 05 Month 10 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2018 Year 05 Month 10 Day

Last modified on

2019 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035025


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name