UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047508 |
|---|---|
| Receipt number | R000043871 |
| Scientific Title | Effects of lower limbs elevation on the accuracy and swiftness of the realtime echo-guided intravenous hyperalimentation catheter insertion to internal jugular vein |
| Date of disclosure of the study information | 2022/04/17 |
| Last modified on | 2022/04/17 17:43:58 |
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Basic information
Public title
Effects of lower limbs elevation on the accuracy and swiftness of the realtime echo-guided intravenous hyperalimentation catheter insertion to internal jugular vein
Acronym
Effects of lower limbs elevation on the accuracy and swiftness of the realtime echo-guided IVH catheter insertion
Scientific Title
Effects of lower limbs elevation on the accuracy and swiftness of the realtime echo-guided intravenous hyperalimentation catheter insertion to internal jugular vein
Scientific Title:Acronym
Effects of lower limbs elevation on the accuracy and swiftness of the realtime echo-guided IVH catheter insertion
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of lower limbs elevation during the echo-guided central venous catheter insertion to internal jugular vein.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time for the procedure
Key secondary outcomes
Number of punctures, Success rate
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
| Maneuver |
Interventions/Control_1
Lower limbs not elevated in inserting catheter.
Interventions/Control_2
Lower limbs elevated in inserting 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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Central venous catheterization was needed.
Key exclusion criteria
In case consent was not obtained.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Umeda |
Organization
International University of Health and Welfare
Division name
Department of General Medicine, School of Medicine (Shioya Hospital)
Zip code
329-2145
Address
77 Tomita, Yaita-City
TEL
0287441155
umeda@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Umeda |
Organization
International University of Health and Welfare
Division name
Department of General Medicine, School of Medicine (Shioya Hospital)
Zip code
329-2145
Address
77 Tomita, Yaita-City
TEL
0287441155
Homepage URL
umeda@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Shioya Hospital
Address
77 Tomita, Yaita-City
Tel
0287441155
umeda@iuhw.ac.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
| 2022 | Year | 04 | Month | 17 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043871
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| Registered date | File name |
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| Registered date | File name |
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