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

Not Applicable

Completed

• Conditions: Vascular Access Complication

• Registration Number: NCT01943474
• Lead Sponsor: C. R. Bard

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-17
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-11-30
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

1. Male or female, age ≥ 18 years or ≤ 89 years old;
2. Capable and willing to give informed consent;
3. English speaking;
4. Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
5. Admitted to study inpatient unit.

Exclusion Criteria

1. Male or female, < 18 years old or > 89 years old;
2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
3. Previous venous grafts or surgery at the target vessel access site;
4. Currently involved in other investigational clinical trials (unless permission is granted by other study principal investigator [PI]);
5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First Attempt Success Rate With Peripheral IV Catheter Placement	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 Outcome Measures

Name	Time	Method
Completion of IV Therapy	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).
Complications of Peripheral IV Therapy	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).
Catheter Dwell Time	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.
Patient Satisfaction At Insertion	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.
Clinician Satisfaction	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.
Adverse Events	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.
Patient Satisfaction Comfort Comparison	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.
Patient Satisfaction With Overall IV Performance	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.

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States