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 range18 Years

SexALL

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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;
✕. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).

What they're measuring

First Attempt Success Rate

Timeframe: At initial IV insertion attempt, generally from 3-15 minutes

Number of Catheter Attempts Required to Complete Successful PIV Placement

Timeframe: At IV insertion attempt, generally from 3-15 minutes

Trial details

NCT IDNCT02449798

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2017-01-13

View on ClinicalTrials.gov More Vascular Access Complication trials