CONCLUSIONS

Randomized Controlled Comparison of IV Catheter with Coiled Tip Guidewire and Conventional Peripheral IV Catheter

Bette K. Idemoto, PhD, RN, ACNS-BC, CCRN CNS & James R. Rowbottom, MD, Anesthesia Dept Chair

University Hospitals Case Medical Center, Cleveland, OH

BACKGROUND RESULTS

Acknowledgements: Dr. Amir Belson, Inventor; Sponsor, Vascular Pathways, Inc.; UHCMC SICU/LT3 Study RNs & Medical-Surgical Dept of Nursing

PURPOSE

METHODS

RESULTS

Seventy percent of hospitalized patients experience frequent intravenous

therapy as a treatment modality.

However, peripheral IVs are often associated with pain/discomfort and

risk of phlebitis, infiltration or infections. Therefore, first attempt

success and dwell time for IV catheters are important outcomes.

Currently first attempt success averages 40% in adults, complications

occur 47% and average IV dwell time is 44 hrs. 50% of PIV lines require

replacement before completion of therapy.

Multiple attempts at insertion and multiple IVs during each admission

result in poor patient and clinician satisfaction as well as unnecessary

costs.

A new peripheral IV catheter technology that uses a proprietary coiled

tip guidewire design previously seen only in central lines is now

available.

This prospective study compared Experimental and Conventional IV

catheters in adult patients.

Outcomes evaluated included: rate of successful placement on first

attempt, complication rates, dwell times, rate of completion of therapy,

patient and clinician satisfaction and overall costs of therapy.

Patient satisfaction with IV insertion for Experimental using a 5 point

Likert Scale:

This study demonstrated that the use of the Experimental IV was feasible for

hospitalized adults, associated with better outcomes without increasing overall

cost of care and significantly improved patient and clinician satisfaction.

Use of the Experimental IV was associated with positive outcomes including

first attempt success, fewer complications, increased dwell time, higher

completion of therapy, and decreased cost of therapy.

Larger studies are needed to validate this technology in other populations and

multiple care settings.

Industry and hospital IRB approval were obtained prior to

beginning

the study.

Adult medical-surgical patients who required a non-emergent IV

catheter were consented and enrolled.

Randomized enrollment was ensured with sealed envelopes, which

were opened once patient consent was obtained.

Data was collected by the Study RNs using a standardized

instrument.

The study was conducted over 4 months: total of 248 patients

(Experimental IV 123 patients, Conventional IV 125 patients).

Outcomes were assessed using parametric and non-parametric

tests.

First Attempt Success Experimental Conventional p-value*

N 123 125 *Two-sided t-test

First Attempt Success 110 89% 59 47% < 0.001

Complication Rates Experimental Conventional p-value*

N 123 125 *Fisher’s exact

Patients with Complications 10 8% 65 52% < 0.001

Dwell Time Experimental Conventional p-value

N Mean Std N Mean Std

Dwell Time (Days) 120 4.4 2.5 105 1.5 1.0 < 0.001

Dwell Time (Hours) 105 61 35 25 *Fisher’s exact

With INS (Infusion Nursing Society) standards now stating IVs can dwell until

complication, there is significant opportunity to improve patient outcomes with

guidewire technology that offers greater first attempt success and longer

dwell time with Experimental IV.

Completion of Therapy Experimental Conventional p-value*

N 123 125 < 0.001

Completion of Therapy** 110 89% 43 34% *Two-sided Fisher’s exact

Complications including infiltration, phlebitis, occlusion, infection occurred only 8%

of the time with Experimental and 52% with Conventional.

Dwell time significantly improved with Experimental at mean of 4.4 days compared

to Conventional IVs at 1.5 days.

**Completion of therapy defined as original IV in place until no longer needed.

Overall clinician satisfaction for Experimental using a 5 point Likert

scale scored a mean of 4.5.

Cost savings (Return on Investment model) was significant due to the

need to start and restart 50% fewer peripheral IVs.

The study included 248 patients total: 123 Experimental; 125 Conventional

Experimental Intravenous Catheter

Only 13 patients (11%) required a 2nd stick with Experimental compared to 62

(50%) and 4 (3%) a 3rd stick with Conventional.

Actuation Button

Catheter

Needle AccuTip™ Coiled Nitinol

Guidewire

Slider

Overall Patient

Satisfaction

Experimental Conventional p-value*

N Mean SD N Mean SD *two-sided t-

test

At Insertion 123 5 <1 125 3 1 < 0.001

Comfort

Comparison 123 4 1 125 3 1 < 0.001

At Discharge 120 5 <1 107 3 1 < 0.001

OBJECTIVES

1. Describe the benefits of a new Coiled Tip Guidewire IV catheter

2. Describe the impact of the coiled tip IV catheter use on patients’ outcomes.

1. Keogh S. New research: change peripheral intravenous catheters as clinically indicated, not routinely. J Assoc Vasc Access. 2013; 18(3):153-154.

2. Hadaway L. Short peripheral intravenous catheters and infections. Infusion Nursing Society. August 2012; 35(4):230-36.

REFERENCES