UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028481
Receipt number R000032603
Scientific Title Emergency airway management for accidental tracheal extubation in the prone position in a manikin: a simulation study
Date of disclosure of the study information 2017/08/01
Last modified on 2017/11/27 11:47:04

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Basic information

Public title

Emergency airway management for accidental tracheal extubation in the prone position in a manikin: a simulation study

Acronym

Emergency airway management for accidental tracheal extubation in the prone position in a manikin: a simulation study

Scientific Title

Emergency airway management for accidental tracheal extubation in the prone position in a manikin: a simulation study

Scientific Title:Acronym

Emergency airway management for accidental tracheal extubation in the prone position in a manikin: a simulation study

Region

Japan


Condition

Condition

Accidental extubation in the prone position

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation for the most effective re-itubation technique by anesthesiologists for accidental extubation in the prone position in a manikin. Comparison of tracheal intubation performance with Pentax AWS, McGrath videolaryngoscope and Intubating Laryngeal mask Airway in the prone position: a manikin study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intubation time, success rate of intubation and Likert scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Airway management with supraglottic airway device in a manikin

Interventions/Control_2

Tracheal intubation with Pentax AWS in a mainikn

Interventions/Control_3

Tracheal intubation with McGrath videolaryngoscope in a manikin

Interventions/Control_4

Tracheal intubation with intubating laryngeal mask airway in a manikin

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Anesthesiologists at our institution

Key exclusion criteria

The staffs except for anesthesiologists at our institution

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihide Koyama

Organization

Mizonokuchi Hospital, Teikyo University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, 213-8507,Japan

TEL

0448443333

Email

yukihidekoyama1008@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yukihide Koyama

Organization

Mizonokuchi Hospital, Teikyo University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, 213-8507,Japan

TEL

0448443333

Homepage URL


Email

yukihidekoyama1008@gmail.com


Sponsor or person

Institute

Department of Anesthesiology, Mizonokuchi Hospital, Teikyo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Mizonokuchi Hospital, Teikyo University School of Medicine

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

帝京大学医学部附属溝口病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 01 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

2017 Year 07 Month 20 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 21 Day

Last follow-up date

2017 Year 09 Month 30 Day

Date of closure to data entry

2017 Year 10 Month 01 Day

Date trial data considered complete

2017 Year 10 Month 01 Day

Date analysis concluded

2017 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 01 Day

Last modified on

2017 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032603