Tokyo, Jan. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059477) titled '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' on Jan. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Fujita Health University Hospital
Condition:
Condition - Diseases for which your doctor has determined that you need a peripherally indwelling central venous catheter (PICC) for treatment.
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 01 Day
Anticipated trial start date - 2026 Year 01 Month 05 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067968
Disclaimer: Curated by HT Syndication.