UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045555 |
|---|---|
| Receipt number | R000051474 |
| Scientific Title | Ultrasound-guidance versus landmark for difficult peripheral intravenous cannulation : A randomized, open-label, controlled trial |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/03/27 15:06:19 |
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Basic information
Public title
Ultrasound-guidance versus landmark for difficult peripheral intravenous cannulation : A randomized, open-label, controlled trial
Acronym
Ultrasound-guidance versus landmark for difficult peripheral intravenous cannulation : A randomized, open-label, controlled trial
Scientific Title
Ultrasound-guidance versus landmark for difficult peripheral intravenous cannulation : A randomized, open-label, controlled trial
Scientific Title:Acronym
Ultrasound-guidance versus landmark for difficult peripheral intravenous cannulation : A randomized, open-label, controlled trial
Region
| Japan |
Condition
Condition
Emergency medicine
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the ultrasound-guidance group has a significantly higher initial puncture success rate than the conventional landmark group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First puncture success rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of ultrasonography
Interventions/Control_2
Not using ultrasonography
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In order to participate in this study, all of the following criteria must be met.
1) Those who were transported to our hospital by ambulance.
2) Those who have difficult veins which are suitable for cannulation (Modified A-DIVA scale (Adult Difficult Intra Venous Access Scale): 2 points or more)
3) Those who have obtained written informed consent for participation in the research
4) Those who are 18 years of age or older at the time of obtaining informed consent
Key exclusion criteria
If any of the following criteria are met, people will not be able to participate in this study.
1) Those who cannot obtain informed consent
2) Those who need urgent care
3) Those who are pregnant
4) Principal investigators and research coordinator decide it inappropriate to include in this research
5) Those who have already participated in this study
Target sample size
164
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Kimura |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Emergency and Critical Care Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-city Tokyo Japan
TEL
03-3202-7181
akimura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Sugawara |
Organization
Center Hospital of the National Center for Global Health and Medicine
Division name
Emergency and Critical Care Center
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-city Tokyo Japan
TEL
03-3202-7181
Homepage URL
fsugawara@hosp.ncgm.go.jp
Sponsor or person
Institute
Center Hospital of the National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Center Hospital of the National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center Hospital of the National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjuku-city Tokyo Japan
Tel
0332027181
fsugawara@hosp.ncgm.go.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051474
