Safety verification study of the new peripheral intravenous catheter

JRCT ID: jRCTs032200076

Registered date:03/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Which are needed administrations of stimulating drugs (excluding anticancer drugs)
• Date of first enrollment: 31/08/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Venipuncturing with unapproved peripheral intravenous catheter

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kurokawa Mineo
• Source(s) of Monetary Support: Terumo Corporation