UMIN-CTR Clinical Trial

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
Institute	Shinshu University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020480