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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036943
Receipt No. R000037043
Scientific Title The utility of ultrasound-guided central venous cannulation by hand-held ultrasound device
Date of disclosure of the study information 2019/06/03
Last modified on 2019/06/09

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Basic information
Public title The utility of ultrasound-guided central venous cannulation by hand-held ultrasound device
Acronym Central venous cannulation by hand-held ultrasound device; non-inferiority trial
Scientific Title The utility of ultrasound-guided central venous cannulation by hand-held ultrasound device
Scientific Title:Acronym Central venous cannulation by hand-held ultrasound device; non-inferiority trial
Region
Japan

Condition
Condition Patients aged 20-85 years with ASA-PS 1 or 2 who are planed to undergo general anesthesia.
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 Comparison of the effectiveness and safety with central venous cannulation between hand-held and conventional ultrasound device.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration of the procedure from internal jugular vein puncture to confirmation of guidewire placement.
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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patients undergoing central venous cannulation by hand-held ultrasound device (Vscan Dual Probe, GE Healthcare)
Interventions/Control_2 Patients undergoing central venous cannulation by ultrasound device (EDGE,Sonosite)
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 Patients in regular surgery with ASA-PS 1 or 2, undergoing right internal jugular vein catheter placement under general anesthesia.
Key exclusion criteria Patients with abnormalities or infection on puncture site, abnormalities of right jugular vein and artery including thrombosis, histories of head and neck surgeries or radiation, difficulties of right internal jugular vein imaging, BMI > 35 and severe lung 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 Anesthesiology
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 Anesthesiology
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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 03 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 56
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason to presentate the result in the meeting in advance.
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 Completed
Date of protocol fixation
2018 Year 05 Month 06 Day
Date of IRB
2017 Year 10 Month 05 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
2019 Year 03 Month 23 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037043

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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