Clinical trial NCT01943474: AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Keywords: 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
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First Attempt Success Rate With Peripheral IV Catheter Placement
timeFrame: At catheter placement, an expected average of 10 minutes
Secondary outcomes:
measure: Completion of IV Therapy
timeFrame: Study exit/At catheter removal (~ up to 7 days)
measure: Complications of Peripheral IV Therapy
timeFrame: From during to post IV catheter placement up to study exit (~ up to 7 days)
measure: Catheter Dwell Time
timeFrame: Study Exit/At catheter removal (~ up to 7 days)
measure: Patient Satisfaction At Insertion
timeFrame: At catheter insertion, initial 3-15 minutes after insertion procedure completed.
measure: Clinician Satisfaction
timeFrame: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)
measure: Adverse Events
timeFrame: During and post IV catheter placement until study exit (maximum of 6 months).
measure: Patient Satisfaction Comfort Comparison
timeFrame: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.
measure: Patient Satisfaction With Overall IV Performance
timeFrame: At IV removal (usually after 1-7 days of IV dwell time)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: James Rowbottom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Bette Idemoto, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: