UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017670
Receipt number R000020480
Scientific Title The thick peripheral venous cannulation adapting Seldinger's technique: a manikin study
Date of disclosure of the study information 2015/05/26
Last modified on 2022/05/30 10:01:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The thick peripheral venous cannulation adapting Seldinger's technique: a manikin study

Acronym

The thick peripheral venous cannulation adapting Seldinger's technique: a manikin study

Scientific Title

The thick peripheral venous cannulation adapting Seldinger's technique: a manikin study

Scientific Title:Acronym

The thick peripheral venous cannulation adapting Seldinger's technique: a manikin study

Region

Japan


Condition

Condition

Manikin

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We developed a 16G intravenous catheter with a thick inner needle for the Seldinger technique to secure a large-diameter peripheral cannula using a mannequin model, we tried to ascertain whether the success rate of the placement of indwelling cannula had increased.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We tried to ascertain whether the success rate of the placement of indwelling cannula had increased.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We developed a 16G intravenous catheter with a thick inner needle for the Seldinger technique to secure a large-diameter peripheral cannula

Interventions/Control_2

The puncture was performed in accordance with the Seldinger technique using a conventional 16G indwelling intravenous catheter.

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

Anesthesiologist

Key exclusion criteria

None

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Susumu
Middle name
Last name Ide

Organization

Shinshu University

Division name

Anesthesiology

Zip code

3808621

Address

Asahi 3-1-1, Matsumoto, Japan

TEL

0263-37-2670

Email

ide@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Susumu
Middle name
Last name Ide

Organization

Shinshu University

Division name

Anesthesiology

Zip code

3808621

Address

Asahi 3-1-1, Matsumoto, Japan

TEL

0263-37-2670

Homepage URL


Email

ide@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University

Address

3-1-1 Asahi, Matsumoto

Tel

0263-37-2670

Email

ide@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

2015 Year 05 Month 26 Day


Related information

URL releasing protocol

Shinshu University

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

20

Results

The results are useful.

Results date posted

2022 Year 05 Month 30 Day

Results Delayed

Delay expected

Results Delay Reason

The manuscript are reviewed.

Date of the first journal publication of results


Baseline Characteristics

Healthey human

Participant flow

Voluntary

Adverse events

None

Outcome measures

Rate of success

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 05 Month 25 Day

Date of IRB

2014 Year 05 Month 01 Day

Anticipated trial start date

2015 Year 05 Month 26 Day

Last follow-up date

2020 Year 05 Month 23 Day

Date of closure to data entry

2020 Year 05 Month 23 Day

Date trial data considered complete

2020 Year 05 Month 23 Day

Date analysis concluded

2020 Year 05 Month 23 Day


Other

Other related information



Management information

Registered date

2015 Year 05 Month 25 Day

Last modified on

2022 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020480


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name