Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department

C. R. Bard120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Vascular Access Complication

Interventions

AccuCath 2.25" BC Intravascular CatheterDEVICE

Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

North Shore - Long Island Jewish Health System

Manhasset, New York, United States

Outcomes

Primary Outcomes

First Attempt Success Rate

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

Number of Catheter Attempts Required to Complete Successful PIV Placement

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

Secondary Outcomes

Time to Catheter Placement

Time will be measured from initial vessel insertion through successful cannulation

Time frame: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes

Complications

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: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days

Dwell Time

IV dwell time in hours until IV is no longer needed or complicates.

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)

Completion of Therapy

Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.

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

Patient Satisfaction

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.

Data from ClinicalTrials.gov

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