UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059477 |
|---|---|
| Receipt number | R000067968 |
| Scientific Title | A single-centre, anteroposterior study of variation in the insertion tip position of peripherally inserted central venous catheters (PICC) with upper limb position and respiratory phase in Japanese adults. |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/10/20 20:37:21 |
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Basic information
Public title
A clinical study of variations in the insertion tip position of peripherally indwelling central venous catheters (PICC) with upper limb position and respiration in Japanese subjects.
Acronym
Clinical study of peripheral indwelling central venous catheter (PICC) insertion tip position variation in Japanese subjects.
Scientific Title
A single-centre, anteroposterior study of variation in the insertion tip position of peripherally inserted central venous catheters (PICC) with upper limb position and respiratory phase in Japanese adults.
Scientific Title:Acronym
Peripherally Inserted Central Venous Catheter (PICC) insertion tip position variation study in Japanese adults.
Region
| Japan |
Condition
Condition
Diseases for which your doctor has determined that you need a peripherally indwelling central venous catheter (PICC) for treatment.
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Previous studies have found that the insertion tip position of peripherally indwelling central venous catheters (PICCs) depends on the position of the upper limb and respiration, but no studies have been conducted in Japanese adults. The optimal position of the tip of the PICC is often discussed because the PICC is considered to be a central venous catheter (CVC), and there are still differences of opinion in articles and guidelines, including whether PICCs, which strictly speaking have different purposes and structures, should have the same optimal tip position as CVCs. The issue is still controversial, with differing opinions in papers and guidelines.
In this study, we investigated the upper limb position and respiratory variability of the PICC insertion tip position in Japanese adults to identify PICC tip position variability specific to Japanese adults, which may serve as a reference limb position and respiratory phase when determining the optimal PICC insertion tip position in Japanese adults. The results of this study are as follows.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in PICC insertion tip position during upper limb elevation and upper trunk side.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The study was performed in the fluoroscopy room by a nurse practitioner (NP) who was authorized by the medical safety committee of the Nurse Practitioner (NP) office to insert a PICC alone under the direction of a physician, between the date of approval by the ethics review committee of his/her institution and 31 March 2026, for each of the following patients Data on the variation of the PICC insertion tip position according to upper limb position and respiratory phase will be collected in Japanese adult patients with PICC (Groshong Catheter) insertion from the right upper limb, who agreed to the study and were requested by a physician in the department of medicine.
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
-Persons who have received a full explanation of the research content and have given their free and voluntary written consent on the basis of full understanding
-Persons who are 18 years or older at the time of obtaining consent
Key exclusion criteria
-Persons with an object (e.g. pacemaker) already present in the body that may interfere with PICC insertion or tip positioning
-Persons with significant macrovascular or cardiac malformations
-Persons with significant spinal curvature
-Persons with difficulty holding position
-Persons with breathing instability
-Persons with difficulty communicating
-Pregnant women
-Persons for whom the principal investigator or research assistant has Those who are judged by the principal investigator or research assistant to be ineligible for the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | RIE |
| Middle name | |
| Last name | NOBE |
Organization
Fujita Health University Hospital
Division name
Department of Nurse Practitioners
Zip code
470-1192
Address
1-98, Tarakukekubo, Kutsugake-cho, Toyoake City, Aichi Prefecture, Japan
TEL
0562-93-9275
rie.nobe@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | RIE |
| Middle name | |
| Last name | NOBE |
Organization
Fujita Health University Hospital
Division name
Department of Nurse Practitioners
Zip code
470-1192
Address
1-98, Tarakukekubo, Kutsugake-cho, Toyoake City, Aichi Prefecture, Japan
TEL
0562-93-9275
Homepage URL
rie.nobe@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Hospital
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
Fujita Health University Hospital
Address
1-98, Tarakugakubo, Kutsugake-cho, Toyoake City, Aichi Prefecture, Japan
Tel
0562-93-9275
rie.nobe@fujita-hu.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
| 2026 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | 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
Management information
Registered date
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067968
