Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Pat… (NCT02449798) | Clinical Trial Compass
CompletedNot Applicable
Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
United States120 participantsStarted 2015-03
Plain-language summary
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, age \> 18 years old;
. Capable and willing to give informed consent;
. English speaking;
. Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
. Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
. Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.
Exclusion criteria
. Male or female, \< 18 years old;
. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
. Previous venous grafts or surgery at the target vessel access site;
. Subjects with lymphedema or status-post mastectomy on affected side;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested the AccuCath 2.25" Blood Control catheter specifically in patients who were considered 'difficult access' in the emergency department — how would my doctor determine whether I fall into that category, and does that label affect my broader treatment plan?
2Since this trial was focused on measuring first-attempt success rates and how many tries it took to get an IV placed, what does that mean practically for me — if standard IV placement has already been a problem, is there a device or technique my care team currently uses that addresses this?
3This study is listed as 'Phase NA,' which often means it was testing a device or procedure rather than a drug — so what is the current standard of care for difficult IV access in my situation, and how does the AccuCath approach compare to what my hospital already offers?
4Since the trial is now completed, has my doctor seen the results, and do those findings change how they would approach getting IV access in someone like me?
5If getting reliable vascular access has been or might be a challenge in my care, what alternatives exist beyond a standard peripheral IV — such as a midline catheter or central line — and how would my doctor decide which option is safest for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First Attempt Success Rate
Timeframe: At initial IV insertion attempt, generally from 3-15 minutes
2
Number of Catheter Attempts Required to Complete Successful PIV Placement
Timeframe: At IV insertion attempt, generally from 3-15 minutes