Manhasset, New York 11030


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Male or female, age > 18 years old; 2. Capable and willing to give informed consent; 3. English speaking; 4. Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician; 5. Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay; 6. 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: 1. Male or female, < 18 years old; 2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement); 3. Previous venous grafts or surgery at the target vessel access site; 4. Subjects with lymphedema or status-post mastectomy on affected side; 5. Currently involved in other investigational clinical trials (unless permission is granted by other study PI).


NCT ID:

NCT02449798


Primary Contact:

Principal Investigator
Christopher Raio, MD
North Shore Long Island Jewish Health System

Christopher Raio, MD
Phone: 631-988-7181
Email: craio@NSHS.EDU


Backup Contact:

Email: rellsperman@NSHS.EDU
Rob Ellsperman, MD
Phone: 478-737-0917


Location Contact:

Manhasset, New York 11030
United States

Christopher Raio, MD
Phone: 631-988-7181
Email: craio@NSHS.EDU

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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