North Shore - Long Island Jewish Health System
Manhasset, New York, 11030, United States
NCT Number: NCT02449798
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Manhasset, New York, 11030, United States
A one arm, prospective feasibility study using the AccuCath 2.25" BC Intravascular Catheter System placed in the upper arm with ultrasound guidance, and the lower arm with and without ultrasound guidance based on clinical assessment. Subjects will be subjected to a maximum of 4 attempts. If unsuccessful by the 4th attempt, alternatives will be considered as per current standard of care.
Currently multiple IV attempts are made in difficult IV access patients without success. Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication. The study will evaluate the feasibility of AccuCath 2.25" BC as a low risk, lower cost alternative for this patient population in lieu of using a midline, peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.
Other names: AccuCath, AccuCath peripheral IV, AccuCath IV device, AccuCath catheter system
Time frame: At initial IV insertion attempt, generally from 3-15 minutes
Time frame: At IV insertion attempt, generally from 3-15 minutes
Time frame: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes
Time will be measured from initial vessel insertion through successful cannulation
Time frame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site
Time frame: Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)
IV dwell time in hours until IV is no longer needed or complicates.
Time frame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.
Time frame: At end of IV insertion, first 3-15 minutes of procedure
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Time frame: at IV removal, which can be up to a maximum of 29 days
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Time frame: Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts
Count of catheter attempts during initial insertion before patient identified as difficult IV access
C. R. Bard
Industry
A Prospective Feasibility Trial of AccuCath 2.25" BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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