UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057297 |
|---|---|
| Receipt number | R000065499 |
| Scientific Title | Factors contributing to difficult venipuncture during peripherally inserted central catheter placement and their association with complication risk |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2025/08/27 07:12:43 |
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Basic information
Public title
An observational study on factors contributing to difficult venipuncture during peripherally inserted central catheter placement and their association with complication risk
Acronym
An observational study on factors contributing to difficult venipuncture during PICC placement and their association with complication risk
Scientific Title
Factors contributing to difficult venipuncture during peripherally inserted central catheter placement and their association with complication risk
Scientific Title:Acronym
Factors influencing difficult venipuncture during PICC placement and their association with complication risk
Region
| Japan |
Condition
Condition
patients requiring a central intravenous line
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is to identify the causes of difficulty in venipuncture during PICC insertion.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between difficult venipuncture cases and associated complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anatomical differences (vessel diameter and depth) between cases in which venipuncture was possible at the first time of implantation of peripherally inserted central venous catheters and cases in which two or more punctures were required
Key secondary outcomes
Venipuncture time
Complications rate(bloodstream infection, hemorrhage at the insertion site, phlebitis, vein thrombosis, and catheter malfunction such as partial/complete occlusion and fracture)
(hematoma,extravasation,injury to surrounding tissues,thrombophlebitis,thrombosis,catheter-related bloodstream infection,unintentional self-removal or catheter malfunction such as partial or complete occlusion and fracture
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which a suitable vein for PICC placement was identified using ultrasound.
A written informed consent was obtained.
Key exclusion criteria
Cases in which a suitable vein for PICC placement could not be identified using ultrasound.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Maoto |
| Middle name | |
| Last name | Yokomizo |
Organization
Yokosuka General Medical Center
Division name
Department of Emergency Medicine
Zip code
2398567
Address
1-8,Shinmeicho,Yokosuka-city,Kanagawa,Japan
TEL
0570032630
d2425@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Maoto |
| Middle name | |
| Last name | Yokomizo |
Organization
Yokosuka General Medical Center
Division name
Department of Emergency Medicine
Zip code
2398567
Address
1-8,Shinmeicho,Yokosuka-city,Kanagawa,Japan
TEL
0570032630
Homepage URL
d2425@jichi.ac.jp
Sponsor or person
Institute
Yokosuka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokosuka General Medical Center
Address
1-8,Shinmeicho,Yokosuka-city,Kanagawa,Japan
Tel
0570032630
d2425@jichi.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
| 2025 | Year | 03 | 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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Population
Hospitalized patients at Yokosuka General Medical Center
Age criteria: 18 years or older
Sex: Both male and female
Eligibility Criteria
Inclusion criteria:Patients in whom a suitable vein for PICC placement is identified using ultrasound.
Exclusion criteria:Patients in whom a suitable vein for PICC placement cannot be identified using ultrasound.
Recruitment Method
Informed consent will be obtained from patients undergoing PICC insertion at our institution.
Study Period
From: May 10, 2024
To: March 31, 2028
Measurement Items
Pre-puncture assessments: Depth from the epidermis to the anterior wall of the target vein (mm),Vertical and transverse vein diameters
During puncture:Number of puncture attempts,Time required for the first successful puncture (measured from skin puncture to ultrasound confirmation of the guidewire in the vessel, using either a short-axis or long-axis view)
Operator Information:Number of previous PICC insertions performed or total years of experience
Complications:Hematoma,Extravasation,Nerve or arterial injury,Thrombophlebitis,Thrombosis,Catheter-relatedbloodstreaminfection(CRBSI),Unintentionalself-removal,Catheter damage or occlusion
Observation Period:From PICC placement until removal, or until the date of hospital discharge if the catheter remains in place.
Discontinuation Criteria:The study will be discontinued if it is determined that the measurements cause clear harm or disadvantage to the patient.
Management information
Registered date
| 2025 | Year | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065499
