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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040430
Receipt No. R000046138
Scientific Title Ultrasound-guided central venipuncture using pocket-sized versus standard ultrasound devices: a prospective non-inferiority trial
Date of disclosure of the study information 2020/05/19
Last modified on 2020/05/18

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Basic information
Public title Ultrasound-guided central venipuncture using pocket-sized ultrasound device
Acronym Ultrasound-guided central venipuncture using pocket-sized ultrasound device
Scientific Title Ultrasound-guided central venipuncture using pocket-sized versus standard ultrasound devices: a prospective non-inferiority trial
Scientific Title:Acronym Ultrasound-guided central venipuncture using pocket-sized versus standard ultrasound devices: a prospective non-inferiority trial
Region
Japan

Condition
Condition Subjects 20 to 85 years of age with American Society of Anesthesiologists Physical Status 1 or 2 who underwent scheduled surgery with general anesthesia and right internal jugular vein catheter placement
Classification by specialty
Cardiology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Obsterics and gynecology Dermatology Urology
Anesthesiology Neurosurgery Cardiovascular surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the non-inferiority of pocket-sized ultrasound devices for ultrasound-guided internal jugular venipuncture in comparison with standard ultrasound devices by evaluating the differences in their performance
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes puncture time between the venipuncture and imaging guidewire placement by ultrasound devices
Key secondary outcomes number of punctures, artificial(guidewire and needle) visibility, and anatomic visibility by ultrasound devices

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 Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Central venipuncture using Vscan Dual Probe (GE Healthcare, Tokyo, Japan) as a pocket-sized ultrasound device (PUD): Group P.

Interventions/Control_2 Central venipuncture using SonoSite EDGE and HFL 50/15-6 linear probe (SonoSite Japan Co., Tokyo, Japan) as a standard ultrasound device (SUD) : Group S.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 20 to 85 years of age with American Society of Anesthesiologists Physical Status 1 or 2 who underwent scheduled surgery with general anesthesia and right internal jugular vein catheter placement
Key exclusion criteria The following exclusion criteria were applied: patients with skin abnormalities in the neck region, abnormally running right cervical blood vessels, venous thrombus during the ultrasound prescan, collapse of the right cervical blood vessels during the ultrasound prescan, history of cervical radiation or operation, body mass index 35 kg/m2 or higher, or severe pulmonary complications.
Target sample size 56

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Yamamoto
Organization Nayoro City General Hospital
Division name Dept. of Anesthesia
Zip code 0968511
Address 1, minami 8 - nishi 7, Nayoro-city, Hokkaido, Japan
TEL 01654-3-3101
Email cab55640@yahoo.co.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Yamamoto
Organization Nayoro City General Hospital
Division name Dept. of Anesthesia
Zip code 0968511
Address 1, minami 8 - nishi 7, Nayoro-city, Hokkaido, Japan
TEL 01654-3-3101
Homepage URL
Email cab55640@yahoo.co.jp

Sponsor
Institute Nayoro City General Hospital
Institute
Department

Funding Source
Organization no funding sources
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 Nayoro City General Hospital
Address 1, minami 8 - nishi 7, Nayoro-city, Hokkaido, Japan
Tel 01654-3-3101
Email cab55640@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 名寄市立総合病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 19 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 06 Day
Date of IRB
2017 Year 10 Month 05 Day
Anticipated trial start date
2020 Year 05 Month 20 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 18 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046138

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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