Clinical trial NCT02449798: Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Keywords: Difficult IV access
AccuCath
IV outcomes
patient satisfaction
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: First Attempt Success Rate
timeFrame: At initial IV insertion attempt, generally from 3-15 minutes
measure: Number of Catheter Attempts Required to Complete Successful PIV Placement
timeFrame: At IV insertion attempt, generally from 3-15 minutes
Secondary outcomes:
measure: Time to Catheter Placement
timeFrame: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes
measure: Complications
timeFrame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
measure: Dwell Time
timeFrame: 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)
measure: Completion of Therapy
timeFrame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
measure: Patient Satisfaction
timeFrame: At end of IV insertion, first 3-15 minutes of procedure
measure: Patient Satisfaction
timeFrame: at IV removal, which can be up to a maximum of 29 days
Other outcomes:
measure: Number of Attempts Prior to AccuCath 2.25" Use
timeFrame: 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
Locations:
city: Manhasset
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
Study officials:
affiliation: Northwell Health
name: Christopher Raio, MD
role: PRINCIPAL_INVESTIGATOR
References: