UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038968
Receipt number R000044441
Scientific Title The simulation study for accidental tracheal extubation during surgery with prone patients.
Date of disclosure of the study information 2019/12/24
Last modified on 2021/06/28 11:08:53

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Basic information

Public title

The simulation study for accidental tracheal extubation during surgery with prone patients.

Acronym

The simulation study for accidental tracheal extubation during surgery with prone patients.

Scientific Title

The simulation study for accidental tracheal extubation during surgery with prone patients.

Scientific Title:Acronym

The simulation study for accidental tracheal extubation during surgery with prone patients.

Region

Japan


Condition

Condition

Accidental tracheal extubation in the prone position

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to investigate the most reliable device for airway rescue in the prone position.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time from the start of airway management to the first successful ventilation for the simulation manikin through the inserted device.

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Volunteer anesthesiologists in Yokohama City University Hospital

Key exclusion criteria

None

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Miyashita

Organization

Yokohama City University Hospital

Division name

Department of Anesthesiology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

0457872918

Email

yushukyo@yahoo.co.jp


Public contact

Name of contact person

1st name Natsuhiro
Middle name Yamamoto
Last name Yamamoto

Organization

Yokohama City University Hospital

Division name

Department of Anesthesiology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

TEL

0457872918

Homepage URL


Email

natsuyamamo@gmail.com


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

None

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

Yokohama City University Hospital IRB

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

Tel

045-370-7627

Email

rinri@yokohama-cu.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

2019 Year 12 Month 24 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

2019 Year 12 Month 20 Day

Date of IRB

2019 Year 12 Month 20 Day

Anticipated trial start date

2019 Year 12 Month 20 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is an observational study about airway management for the manikin set prone, performed by anesthesiologists in Yokohama City University Hospital.


Management information

Registered date

2019 Year 12 Month 24 Day

Last modified on

2021 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044441


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name