UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045269
Receipt number R000051700
Scientific Title Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study
Date of disclosure of the study information 2021/09/13
Last modified on 2023/08/28 13:27:40

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Basic information

Public title

Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study

Acronym

Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study

Scientific Title

Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study

Scientific Title:Acronym

Near-infrared vascular imaging versus ultrasound to guide difficult peripheral intravenous catheterization, a comparative simulation study

Region

Japan


Condition

Condition

Peripheral intravenous catheterization

Classification by specialty

Pediatrics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We compare near-infrared vascular imaging with ultrasound guidance for difficult vascular access by using a peripheral intravascular catherization simulator in simulation training setting.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total number of catheterization trials from start to three consecutive successes.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

Near-infrared vascular imaging

Interventions/Control_2

Ultrasound guiding

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

21 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Medical students who have no or scant experience in peripheral intravenous catheterization

Key exclusion criteria

None

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Joho
Middle name
Last name Tokumine

Organization

Kyorin University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 Japan

TEL

0422-47-5511

Email

kawatetsujoho6996@yahoo.co.jp


Public contact

Name of contact person

1st name Shinichiro
Middle name
Last name Sekiguchi

Organization

Kyorin University Faculty of Medicine

Division name

Department of Medical Education

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 Japan

TEL

0422-47-5511

Homepage URL


Email

ssekiguchi@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University Faculty of Medicine
Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Kyorin University Faculty of Medicine
Department of Anesthesiology and Department of Medical Education

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

Kyorin University School of Medicine

Address

6-20-2 Shinkawa, Mitaka-city, Tokyo, 181-8611 Japan

Tel

0422-47-5511

Email

rec@ks.kyorin-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

杏林大学医学部(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 13 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

41

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 03 Month 24 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

2021 Year 08 Month 23 Day

Date of IRB

2021 Year 09 Month 15 Day

Anticipated trial start date

2021 Year 09 Month 22 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 04 Month 30 Day

Date analysis concluded

2023 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2021 Year 08 Month 26 Day

Last modified on

2023 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051700


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name