UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011502
Receipt number R000012870
Scientific Title Basic and clinical researches for the reliability of the on-line teleanesthesia system using video camera and monitoring in remote place
Date of disclosure of the study information 2013/10/01
Last modified on 2021/02/20 10:48:57

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Basic information

Public title

Basic and clinical researches for the reliability of the on-line teleanesthesia system using video camera and monitoring in remote place

Acronym

Basic and clinical researches for teleanesthesia

Scientific Title

Basic and clinical researches for the reliability of the on-line teleanesthesia system using video camera and monitoring in remote place

Scientific Title:Acronym

Basic and clinical researches for teleanesthesia

Region

Japan


Condition

Condition

scheduled adult patients undergoing surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the relationship between the transmission speed and the image clarity and the clinical efficacy of the on-line teleanesthesia system in remote place.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. The frequency of transmission errors in several transmission speed settings
2. The frequency of adverse event in clinical settings

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

adult scheduled surgical patients

Key exclusion criteria

emergency surgery
scheduled time within 15 minutes
exceed bleeding expected

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Tetsuya
Middle name
Last name Miyashita

Organization

Yokohama City University Hospital

Division name

Anesthesiology

Zip code

236-0004

Address

3-9 Fukuura Kanazawa Yokohama, Japan

TEL

+81-45-787-2918

Email

yushukyo@yahoo.co.jp


Public contact

Name of contact person

1st name Tetsuya
Middle name
Last name Miyashita

Organization

Yokohama City University Hospital

Division name

Anesthesiology

Zip code

236-0004

Address

3-9 Fukuura kanazawa Yokohama, Japan

TEL

+81-45-787-2918

Homepage URL


Email

yushukyo@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name



Funding Source

Organization

Niigata-ken Kouseiren

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sado General Hospital

Address

1-1 Kanai; Sado. INiigata

Tel

0259-63-3121

Email

yushukyo@yahoo.co.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

佐渡総合病院


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 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

100

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2015 Year 03 Month 01 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB

2013 Year 10 Month 01 Day

Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date

2021 Year 02 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Delay time and flame loss of images in guaranteed transmission speeds

Adverse events during tele-anesthesia
Stability of communications during tele-anesthesia


Management information

Registered date

2013 Year 08 Month 16 Day

Last modified on

2021 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012870


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name