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Completed

NCT Number: NCT01943474

AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters.

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Key information

Conditions

Vascular Access Complication

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.

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 or ≤ 89 years old;
  • Capable and willing to give informed consent;
  • English speaking;
  • Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
  • Admitted to study inpatient unit.

Exclusion criteria

  • Male or female, < 18 years old or > 89 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;
  • Currently involved in other investigational clinical trials (unless permission is granted by other study principal investigator [PI]);
  • Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

Treatment and study plan

AccuCath IV Catheter Device

Device

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Other names: Rapid Intravascular Start System (RIVS), AccuCath System, AccuCath IV device, AccuCath, AccuCath PIV, AccuCath Short IV, AccuCath IV Catheter

Conventional IV Catheter Device

Device

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.

Other names: Insyte Autoguard, Insyte Autoguard PIV, Insyte Autoguard IV Catheter, Insyte Autoguard IV device

Primary outcomes

  1. First Attempt Success Rate With Peripheral IV Catheter Placement

    Time frame: At catheter placement, an expected average of 10 minutes

    The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.

Secondary outcomes

  1. Completion of IV Therapy

    Time frame: Study exit/At catheter removal (~ up to 7 days)

    Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days).

  2. Complications of Peripheral IV Therapy

    Time frame: From during to post IV catheter placement up to study exit (~ up to 7 days)

    Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days).

  3. Catheter Dwell Time

    Time frame: Study Exit/At catheter removal (~ up to 7 days)

    Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.

  4. Patient Satisfaction At Insertion

    Time frame: At catheter insertion, initial 3-15 minutes after insertion procedure completed.

    Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

  5. Clinician Satisfaction

    Time frame: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)

    Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

  6. Adverse Events

    Time frame: During and post IV catheter placement until study exit (maximum of 6 months).

    Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.

  7. Patient Satisfaction Comfort Comparison

    Time frame: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.

    Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

  8. Patient Satisfaction With Overall IV Performance

    Time frame: At IV removal (usually after 1-7 days of IV dwell time)

    Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison by General Hospital Nursing Staff

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2013
Registry last updated
Mar 9, 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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