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Completed

NCT Number: NCT02449798

Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore - Long Island Jewish Health System

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: AccuCath, AccuCath peripheral IV, AccuCath IV device, AccuCath catheter system

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 20, 2015
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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