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Safety verification study of the new peripheral intravenous catheter

Safety verification study of the new peripheral intravenous catheter for reducing catheter failure incidence: An exploratory study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032200076
Enrollment
10
Registered
2020-08-03
Start date
2020-08-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Which are needed administrations of stimulating drugs (excluding anticancer drugs)

Interventions

Venipuncturing with unapproved peripheral intravenous catheter

Sponsors

Kurokawa Mineo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Who are scheduled to administrate stimulating drugs* (excluding anticancer drugs) using PIVC. (*Cytotoxic agents, Vesicant solutions, Irritant solutions, Hyperosmotic agents) 2)Over 19 years, regardless of gender 3)Who can expect continuous infusion therapy over 24 hours 4)Who have obtained their own written consent

Exclusion criteria

Exclusion criteria: 1)Who are unable to maintain the position to fully rotate the shoulder joint and rotate the elbow joint 2)With skin disorders at the puncture site 3)With peripheral neuropathy 4)With a history of vasovagal reflex due to puncture 5)With a history of thrombosis 6)With end-stage renal disease (stage II or higher) 7)With abnormal blood coagulation or bleeding tendency (PT-INR 1.5 or more, APTT 36.1 seconds or more, while taking any anticoagulant or antiplatelet drug) 8)Who is planned of highly invasive tests (endoscopy, bronchoscopy) 9)Whose physician judges that participation in this study is inappropriate

Design outcomes

Primary

MeasureTime frame
Unexpected device malfunctions and adverse events up to 7 days after placement of the new peripheral intravenous catheter, and Incidence of adverse events up to 24 hours after removal.

Secondary

MeasureTime frame
1)Success rate of catheter placement 2)The incidence of Catheter failure 3)Subjective evaluation of catheter placement in patients

Contacts

Public ContactRyoko Murayama

Gradiate School of Medicine, The University of Tokyo,

rymurayama-tky@umin.ac.jp+81-3-5800-9531

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026