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

NCT02449798 | Completed Results

• 1 other identifier: VPW-STP-00007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Complication

Keywords

Difficult IV access; AccuCath; IV outcomes; patient satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Time to Catheter Placement

  At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes

• Complications

  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

  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

  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

  At end of IV insertion, first 3-15 minutes of procedure

Other Outcomes (1)

• Number of Attempts Prior to AccuCath 2.25" Use

  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

Study Arms (1)

AccuCath 2.25" BC Intravascular Catheter

EXPERIMENTAL

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

Interventions

AccuCath 2.25" BC Intravascular Catheter DEVICE

Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.

Also known as: AccuCath, AccuCath peripheral IV, AccuCath IV device, AccuCath catheter system

AccuCath 2.25" BC Intravascular Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

North Shore - Long Island Jewish Health System

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Gina Gilbert, BSN, RN
• Organization: Bard Access Systems, Inc.

Gina.Gilbert@crbard.com

407-489-0935

Study Officials

• Christopher Raio, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2015
• First Posted: May 20, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)