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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Vascular Access Complication

Intervention / Treatment
-----------------
* Device: AccuCath 2.25 BC Intravascular Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AccuCath 2.25 BC Intravascular Catheter<br>Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins. | Device: AccuCath 2.25 BC Intravascular Catheter<br>* Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.<br>* Other names: AccuCath catheter system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Attempt Success Rate |  | At initial IV insertion attempt, generally from 3-15 minutes | 
| Number of Catheter Attempts Required to Complete Successful PIV Placement |  | At IV insertion attempt, generally from 3-15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Catheter Placement | Time will be measured from initial vessel insertion through successful cannulation | 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 | 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. | 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. | 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. | At end of IV insertion, first 3-15 minutes of procedure | 
| Patient Satisfaction | 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. | at IV removal, which can be up to a maximum of 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Difficult IV access, AccuCath, IV outcomes, patient satisfaction