The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.
Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Evangelical Community Hospital
Lewisburg, Pennsylvania, United States
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt
The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.
Time frame: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure
Percentage of Patients With Complications of Peripheral IV Therapy
Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Completion of IV Therapy
Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Catheter Dwell Time
Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion
Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Time frame: Baseline at catheter insertion in the first 3-15 minutes after procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Participants Experiencing Adverse Events
Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.
Time frame: baseline, and up to catheter removal expected to be no more than 7 days post placement
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal
Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Time frame: At catheter removal, which is expected to be up to 7 days post placement