UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040496
Receipt number R000046019
Scientific Title Effect of a barrier enclosure on tracheal intubation difficulty
Date of disclosure of the study information 2020/05/25
Last modified on 2020/10/05 14:16:39

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Basic information

Public title

Effect of a barrier enclosure on tracheal intubation difficulty

Acronym

Effect of a barrier enclosure on tracheal intubation difficulty

Scientific Title

Effect of a barrier enclosure on tracheal intubation difficulty

Scientific Title:Acronym

Effect of a barrier enclosure on tracheal intubation difficulty

Region

Japan


Condition

Condition

An airway management simulator manikin

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of our study was to determine how the barrier enclosure affects tracheal intubation difficulty.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Outcomes were the first-pass intubation success rate, time to successful tracheal intubation, Cormack-Lehane grade, percentage of glottic opening (POGO) score, peak force to maxillary incisors that was measured by force sensors attached to the manikin.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Tracheal intubation with an aerosol box using a direct laryngoscope

Interventions/Control_2

Tracheal intubation without an aerosol box using a direct laryngoscope

Interventions/Control_3

Tracheal intubation with an aerosol box using a McGRATH MAC videolaryngoscope

Interventions/Control_4

Tracheal intubation without an aerosol box using a McGRATH MAC videolaryngoscope

Interventions/Control_5

Tracheal intubation with an aerosol box using an airway scope AWS-S200NK videolaryngoscope

Interventions/Control_6

Tracheal intubation without an aerosol box using an airway scope AWS-S200NK videolaryngoscope

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

1. Experienced anesthetists who had performed more than 50 tracheal intubations using both a direct laryngoscope and a videolaryngoscope
2. Normal or corrected-to-normal eyesight

Key exclusion criteria

1. Who do not wish to participate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Ryo
Middle name
Last name Wakabayashi

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-8621

Address

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

TEL

+81263372670

Email

waka0924@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Wakabayashi

Organization

Shinshu University School of Medicine

Division name

Department of Anesthesiology and Resuscitology

Zip code

390-8621

Address

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

TEL

+81263372670

Homepage URL


Email

waka0924@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Committee for Medical Ethics of Shinshu University School of Medicine

Address

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

Tel

+81263372572

Email

mdrinri@shinshu-u.ac.jp


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

2020 Year 05 Month 25 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

Completed

Date of protocol fixation

2020 Year 05 Month 17 Day

Date of IRB

2020 Year 05 Month 27 Day

Anticipated trial start date

2020 Year 05 Month 27 Day

Last follow-up date

2020 Year 05 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 22 Day

Last modified on

2020 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name