UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023727 |
|---|---|
| Receipt number | R000027331 |
| Scientific Title | Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT |
| Date of disclosure of the study information | 2016/08/23 |
| Last modified on | 2016/12/26 21:40:22 |
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Basic information
Public title
Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT
Acronym
IV contrast infusion via 24-gauge side-holes catheter
Scientific Title
Selection of peripheral intravenous catheters with 24-gauge side-holes versus those with 22-gauge end-hole for MDCT
Scientific Title:Acronym
IV contrast infusion via 24-gauge side-holes catheter
Region
| Japan |
Condition
Condition
All the patients who were referred for a suspect of pancreatic disease are eligible.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To comparing the 24-gauge side-holes catheter and conventionally used 22-gauge end-hole catheters for the safety, the injection pressure, and the contrast enhancement on multi-detector computed tomography (MDCT).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The safety during intravenous contrast material administration.
Key secondary outcomes
The injection pressure and the contrast enhancement.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Dynamic CT with the 24-gauge side-holes catheter.
Interventions/Control_2
Dynamic CT with the 22-gauge end-hole catheter.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients were randomized if they weighted more than 30 kg, if they were outpatients, and if aged 20 years old or older.
Key exclusion criteria
Exclusion criteria were contraindications to iodinated contrast media, emergency cases, hemodialysis or renal failure patients, pregnant or lactating women, cases unable to place intravenous catheters, and cases with right median cubital vein puncture as an alternative route.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Tamura |
Organization
Iwate Medical University School of Medicine
Division name
Department of Radiology
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
0196515111
a.akahane@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Tamura |
Organization
Iwate Medical University School of Medicine
Division name
Department of Radiology
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
0196515111
Homepage URL
a.akahane@gmail.com
Sponsor or person
Institute
Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University School of Medicine
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
Address
Tel
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
| 2016 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0720048X16303862
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 23 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027331
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| Registered date | File name |
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