UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037910 |
|---|---|
| Receipt number | R000043161 |
| Scientific Title | Real-time ultrasound guided peripherally venous catheter insersion in patients with difficulty in securing peripheral veins |
| Date of disclosure of the study information | 2019/09/04 |
| Last modified on | 2022/03/07 09:33:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Real-time ultrasound guided peripherally venous catheter insersion in patients with difficulty in securing peripheral veins
Acronym
Real-time ultrasound guided peripherally venous catheter insersion
Scientific Title
Real-time ultrasound guided peripherally venous catheter insersion in patients with difficulty in securing peripheral veins
Scientific Title:Acronym
Real-time ultrasound guided peripherally venous catheter insersion
Region
| Japan |
Condition
Condition
patients with difficulty in securing peripheral veins
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness and safety of the peripheral vein securing method for patients with difficulty in securing the peripheral venous route, puncturing the brachial vein under the ultrasound guide andinsersion a catheter shorter than the PICC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of completion
Key secondary outcomes
･ Mean number of times of piercing operations
･ AE of protocol procedure
･ Median time to removal of intravenous catheter
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pre-scan the upper arm with echo and select a vein suitable for puncture insertion. A peripheral venous route is secured using a catheter for measuring peripheral arterial pressure. In principle, the inserted catheter is not sutured to the skin, disinfected again with chlorhexidine alcohol, and dressed with Tegaderm I.V. Advanced.
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) It is necessary to secure a venous route for infusion and drug administration.
2) Peripheral venous route could not be secured by repeated extravasation, obesity, edema, and periodic replacement, or even if multiple attempts were made to insert a normal peripheral venous catheter, it could not be inserted.
3) It is judged that there is no indication of CVC or PICC other than the reason that peripheral venous catheter placement is difficult.
4) The age at the time of registration is more than 15 years old.
5) As for participation in the study, written consent has been obtained from the subject himself / herself or a guardian such as a family member.
Key exclusion criteria
1) Strong bleeding tendency.
2) Due to dementia, etc., it is difficult to maintein the catheter after insertion.
3) It is judged that catheter insertion is difficult anatomically because the veins of the bilateral brachial arms (basilic vein, brachial vein) are narrow, collapsed, thrombus occluded, and/or close to the peripheral nerve.
4) Bilateral upper limb contractures are strong.
5) Have any of the following complications:
･ Skin or subcutaneous tissue infection on both upper arms (cellulitis, etc.)
･ Burns or ulcers on both upper arms
6) Have a history of any of the following:
･ Median nerve palsy or ulnar nerve palsy
･ Complex regional pain syndrome (CRPS)
･ If the subject has cerebral infarction or hemiplegia and need to insert a puncture from the paralyzed side
7) Other subjects who are judged inappropriate by the principal investigator or doctor in charge for conducting this study safely.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Watabe |
Organization
Saku Central Hospital Advanced Care Center
Division name
Emergency Center
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, 385-0051 JAPAN
TEL
0267-62-8181
watabe.osamu@sakuhp.or.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Niimi |
Organization
Saku Central Hospital Advanced Care Center
Division name
Clinical Research Center
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, 385-0051 JAPAN
TEL
0267-62-8181
Homepage URL
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
Funding Source
Organization
Saku Central Hospital Advanced Care Center
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
Saku Central Hospital Group Research Ethics Committee
Address
197 Usuda, Saku, 384-0301 JAPAN
Tel
0267-82-3131
irboffice@sakuhp.or.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
佐久総合病院 佐久医療センター（長野県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 04 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043161
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
