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

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 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.

Study Overview

• Status: Completed
• Conditions: Vascular Access Complication
• Intervention / Treatment: Device: AccuCath 2.25" BC Intravascular Catheter

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore - Long Island Jewish Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 IV device; AccuCath; AccuCath peripheral IV; AccuCath catheter system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: Christopher Raio, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 16, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: patient satisfaction; Difficult IV access; AccuCath; IV outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: VPW-STP-00007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO