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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Vascular Access Complication

Intervention / Treatment
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* Device: AccuCath IV Catheter Device
* Device: Conventional IV Catheter Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AccuCath IV Catheter Device<br>AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal | Device: AccuCath IV Catheter Device<br>* Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.<br>* Other names: AccuCath IV Catheter;|
| Active Comparator: Conventional IV Catheter Device<br>Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal | Device: Conventional IV Catheter Device<br>* Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.<br>* Other names: Insyte Autoguard IV device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Attempt Success Rate With Peripheral IV Catheter Placement | 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. | At catheter placement, an expected average of 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of IV Therapy | 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). | Study exit/At catheter removal (  up to 7 days) | 
| Complications of Peripheral IV Therapy | 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). | From during to post IV catheter placement up to study exit (  up to 7 days) | 
| Catheter Dwell Time | Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter)   up to 7 days. | Study Exit/At catheter removal (  up to 7 days) | 
| Patient Satisfaction At Insertion | 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. | At catheter insertion, initial 3-15 minutes after insertion procedure completed. | 
| Clinician Satisfaction | 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. | At completion of study after all patients have been enrolled (approximately 6 months from study initiation) | 
| Adverse Events | 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. | During and post IV catheter placement until study exit (maximum of 6 months). | 
| Patient Satisfaction Comfort Comparison | 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. | Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure. | 
| Patient Satisfaction With Overall IV Performance | 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. | At IV removal (usually after 1-7 days of IV dwell time) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter Study, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Complication Rates for IV Catheters, Average Dwell Time for IV Catheters, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance