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

Vascular Access Complication Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02449798
• Other study ID #: VPW-STP-00007
• Status: Recruiting
• Phase: N/A
• First received: May 16, 2015
• Last updated: May 19, 2015
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: Vascular Pathways, Inc.
• Contact: Christopher Raio, MD
• Phone: 631-988-7181
• Email: craio[@]NSHS.EDU
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Device:
• AccuCath 2.25" BC Intravascular Catheter
Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.

Locations

Country	Name	City	State
United States	North Shore - Long Island Jewish Health System	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Pathways, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Attempts Prior to AccuCath 2.25" Use	Count of catheter attempts during initial insertion before patient identified as difficult IV access	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	No
Primary	First Attempt Success	Number of catheters attempts required to achieve successful insertion on difficult IV access patients	At initial IV insertion attempt, generally from 3-15 minutes	No
Secondary	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	No
Secondary	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	No
Secondary	Dwell Time	IV dwell time in days/hours until IV is no longer needed or complicates. Includes a count of catheter days.	During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days	No
Secondary	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	No
Secondary	Costs of IV Therapy	Costs of IV therapy compared to alternatives if the AccuCath 2.25" device was not used. These include multiple unsuccessful PIV attempts, non-clinically indicated midlines, PICCs or Central lines.	From IV insertion through removal. Generally ranges from 3 minutes up to 29 days maximum.	No
Secondary	Patient Satisfaction	Likert scale 1-5 measurement of satisfaction with overall IV insertion experience and again at removal with overall IV performance.	At end of IV insertion, first 3-15 minutes of procedure and IV removal, which can by up to a maximum of 29 days	No
Secondary	Clinician Satisfaction	Likert scale 1-5 measurement of satisfaction by IV inserter and again by nurses caring for patient on inpatient unit, completed by the nurse removing the catheter.	At end of IV insertion, first 3-15 minutes of procedure and IV removal, which can by up to a maximum of 29 days	No