The primary study objective was to evaluate insertion success rates. Secondary objectives included patient satisfaction, procedure time, complication rates, completion of therapy and dwell time of the novel AccuCath 2.25″ Blood Control (BC) Catheter System (FDA approved) placed in difficult-access patients. This was a single-arm feasibility trial evaluating the AccuCath 2.25″ BC Catheter System in a convenience sample of DIVA patients defined as at least two failed initial attempts or a history of difficult access plus the inability to directly visualize or palpate a target vein. All enrolled patients were 18 years of age or older. A total of 120 patients were enrolled. These patients had an average of 3.7 and median of 3 prior attempts at vascular access prior to AccuCath placement. Successful access was gained in 100% of the patients, 77% on the first attempt and all within three attempts; 88.5% of patients completed therapy, with the remaining 12.5% experiencing minor complications that required discontinuation of the catheter. The average patient satisfaction score on a 5-point Likert scale was highly positive at 4.6. Preliminary results show that the AccuCath 2.25″ BC Catheter System has excellent success rates in gaining vascular access in an extremely difficult patient population. The device did not lead to any significant complications. Patients were also very satisfied with the procedure.
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