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

• ClinicalTrials.gov Identifier: NCT02449798
• Recruitment Status: Completed
• First Posted: May 20, 2015
• Results First Posted: April 14, 2017
• Last Update Posted: April 14, 2017
• Sponsor: C. R. Bard
• Information provided by (Responsible Party): C. R. Bard

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vascular Access Complication	Device: AccuCath 2.25" BC Intravascular Catheter	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: March 2015
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: AccuCath 2.25" BC Intravascular Catheter; 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; Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.; Other Names: AccuCath; AccuCath peripheral IV; AccuCath IV device; AccuCath catheter system

Outcome Measures

Primary Outcome Measures :

1. First Attempt Success Rate [ Time Frame: At initial IV insertion attempt, generally from 3-15 minutes ]
2. Number of Catheter Attempts Required to Complete Successful PIV Placement [ Time Frame: At IV insertion attempt, generally from 3-15 minutes ]

Secondary Outcome Measures :

1. Time to Catheter Placement [ Time Frame: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes ]
   Time will be measured from initial vessel insertion through successful cannulation
2. Complications [ 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 ]
   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
3. Dwell Time [ 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) ]
   IV dwell time in hours until IV is no longer needed or complicates.
4. Completion of Therapy [ 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 ]
   Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.
5. Patient Satisfaction [ Time Frame: At end of IV insertion, first 3-15 minutes of procedure ]
   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.
6. Patient Satisfaction [ Time Frame: at IV removal, which can be up to a maximum of 29 days ]
   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.

Other Outcome Measures:

1. Number of Attempts Prior to AccuCath 2.25" Use [ Time Frame: 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 ]
   Count of catheter attempts during initial insertion before patient identified as difficult IV access

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, New York

North Shore - Long Island Jewish Health System

Manhasset, New York, United States, 11030

Sponsors and Collaborators

C. R. Bard

Investigators

• Principal Investigator: Christopher Raio, MD; Northwell Health

More Information

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT02449798
• Other Study ID Numbers: VPW-STP-00007
• First Posted: May 20, 2015
• Results First Posted: April 14, 2017
• Last Update Posted: April 14, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by C. R. Bard:

Difficult IV access; AccuCath; IV outcomes; patient satisfaction

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes