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

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 (PIV) 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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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.

Official Title
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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

Conditions
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Vascular Access Complication

Intervention / Treatment
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* Device: AccuCath Intravenous Catheter System


Participation Criteria
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Eligibility Criteria
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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.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AccuCath Intravenous Catheter System<br>AccuCath Intravenous Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. | Device: AccuCath Intravenous Catheter System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt | 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. | Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Complications of Peripheral IV Therapy | 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). | Study exit/at catheter removal expected to be up to 7 days post placement | 
| 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 (generally up to 7 days). | Study exit/at catheter removal expected to be up to 7 days post placement | 
| 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 expected to be up to 7 days post placement | 
| Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion | 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. | Baseline at catheter insertion in the first 3-15 minutes after procedure | 
| Number of Participants Experiencing Adverse Events | 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. | baseline, and up to catheter removal expected to be no more than 7 days post placement | 
| Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal | 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. | At catheter removal, which is expected to be up to 7 days post placement | 

 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