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Completed

NCT Number: NCT01937195

AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) 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

Evangelical Community Hospital

Lewisburg, Pennsylvania, 17837, United States

About this study

Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, age > or equal to 18 years or < or equal to 89 years old;
  • Capable and willing to give informed consent;
  • English speaking;
  • Acceptable candidate for an elective, non-emergent PIV 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 PI);
  • Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

Treatment and study plan

AccuCath Intravenous Catheter System

Device

AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.

Primary outcomes

  1. Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt

    Time frame: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure

    The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.

Secondary outcomes

  1. Percentage of Patients With Complications of Peripheral IV Therapy

    Time frame: Study exit/at catheter removal expected to be up to 7 days post placement

    Will measure the percentage of patients with (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).

  2. Completion of IV Therapy

    Time frame: Study exit/at catheter removal expected to be up to 7 days post placement

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

  3. Catheter Dwell Time

    Time frame: Study exit/at catheter removal expected to be up to 7 days post placement

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

  4. Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion

    Time frame: Baseline at catheter insertion in the first 3-15 minutes after procedure

    Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.

  5. Number of Participants Experiencing Adverse Events

    Time frame: baseline, and up to catheter removal expected to be no more than 7 days post placement

    Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.

  6. Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal

    Time frame: At catheter removal, which is expected to be up to 7 days post placement

    Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters With a Vascular Access Team

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2013
Registry last updated
Apr 20, 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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