Clinical trial NCT01940354: Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
Official title: A Prospective, Randomized, Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complications
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
Patient Satisfaction with IV Catheters
Clinician Satisfaction with AccuCath Device Performance
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 IV placement and higher clinician and patient 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 peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, 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 and higher user and patient satisfaction compared to Conventional IV Catheters.

Eligibility criteria: * Inclusion Criteria:

  1. Male or female, age \> or equal to 18 years or \< or equal to 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 area.

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 PI).

Primary outcomes:
measure: First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
timeFrame: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
Secondary outcomes:
measure: Patient Satisfaction Upon Successful PIV Placement
timeFrame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
measure: Clinician Satisfaction Upon Successful PIV Placement
timeFrame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Scott O Trerotola, BA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosptial of the University of Pennsylvania
name: William Stavropoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Suzanne Sweeney, RN
role: PRINCIPAL_INVESTIGATOR
References: