The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters.
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
University Hospitals Case Medical Center
Cleveland, Ohio, United States
First Attempt Success Rate With Peripheral IV Catheter Placement
The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.
Time frame: At catheter placement, an expected average of 10 minutes
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 (\~ up to 7 days).
Time frame: Study exit/At catheter removal (~ up to 7 days)
Complications of Peripheral IV Therapy
Will measure the rate of observed (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: From during to post IV catheter placement up to study exit (~ up to 7 days)
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 (~ up to 7 days)
Patient Satisfaction At Insertion
Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: At catheter insertion, initial 3-15 minutes after insertion procedure completed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinician Satisfaction
Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)
Adverse Events
Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.
Time frame: During and post IV catheter placement until study exit (maximum of 6 months).
Patient Satisfaction Comfort Comparison
Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.
Patient Satisfaction With Overall IV Performance
Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Time frame: At IV removal (usually after 1-7 days of IV dwell time)