UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036943 |
|---|---|
| Receipt number | 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 | 2020/05/18 11:09:38 |
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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 |
| Obstetrics 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
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
cab55640@yahoo.co.jp
Sponsor or person
Institute
Nayoro City General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037043
