UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040430 |
|---|---|
| Receipt number | 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 | 2020/11/11 21:05:46 |
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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 |
| Obstetrics 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
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
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（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
56
Results
Our findings indicate that PUDs for internal jugular venipuncture have non-inferiority to SUDs with regard to puncture time and number of punctures, despite differences in the visualization potential and device performance.
Results date posted
| 2020 | Year | 11 | Month | 11 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
under publishing
Date of the first journal publication of results
Baseline Characteristics
We recruited 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 between May 20, 2020 and August 31, 2020.
Participant flow
General anesthesia was induced in all patients by infusion of remifentanil (0.3 mcg/kg/min), rocuronium (0.6 mg/kg), and propofol (single-shot of 2 mg/kg or 2.0 to 3.0 mcg/ml using a target-controlled infusion system). General anesthesia was maintained by remifentanil, rocuronium, and propofol or sevoflurane. The ventilator settings were pressure-controlled mechanical ventilation at maximum inspiratory pressure < 20 cmH2O and positive end-expiratory pressure of 5 cmH2O to achieve end-tidal carbon dioxide between 35-40 cmH2O. After induction, all patients were randomly assigned to 1 of 2 groups using sealed opaque envelopes and random number tables that were computer generated by an independent assistant: PUD group (Group P) and SUD group (Group S).
Adverse events
non
Outcome measures
The primary endpoint was puncture time, and the secondary endpoints included number of punctures, artificial visibility, and anatomic visibility.
Plan to share IPD
non
IPD sharing Plan description
non
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
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046138
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