UMIN-CTR Clinical Trial

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	number of punctures, needle and guidewire visibility, and anatomic visibility.

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	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	2020 Year 04 Month 17 Day
Results Delayed	Delay expected
Results Delay Reason	no
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	Terminated
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	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=R000037043