Verification study of the new peripheral intravenous catheter

JRCT ID: jRCTs032210224

Registered date:06/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diseases which are needed administration of stimulating drugs
• Date of first enrollment: 24/08/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Randomization of catheterization using new unapproved peripheral intravenous catheter at the upper arm vein with using a short peripheral intravenous catheter at the forearm vein

Outcome(s)

• Primary Outcome: The incidence rate of catheter failures (%)

Secondary Outcome

1) The incidence rate of catheter failures per 1000 days
2) Presence or absence of a thrombus in the vessel and a subcutaneous edema
3) Signs and symptoms such as redness, swelling, induration and occulusion
4) Subjective evaluation of catheter placement

Key inclusion & exclusion criteria

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

Include criteria

Patients must satisfy the followings; .
1) Patients are scheduled to administrate stimulant drugs using peripheral intravenous catheter.
2) Over 19 years, regardless of gender
3) Patients are scheduled to continuous infusion therapy over 24 hours
4) Patients give us their written consent for the study
5) The first catheterization at this hospitalization

Exclude criteria

The following patients must be excluded.
1) Patients are unable to maintain the position to fully rotate the shoulder joint and rotate the elbow joint
2) Having skin disorders at the puncture site
3) Having peripheral neuropathy
4) Having a history of vasovagal reflex due to puncture
5) Having a history of thrombosis
6) With end-stage renal disease (stage 2 or higher)
7) Having abnormal blood coagulation or bleeding tendency (PT-INR 1.5 or more, APTT 36.1 seconds or more, while taking any anticoagulant or antiplatelet drugs)
8) Patient is planned of highly invasive tests (endoscopy, bronchoscopy)
9) Participation of this study is judged inappropriate for patient by physician

Related Information

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