N/A
N=248
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
Vascular Access Complication
Bottom Line
View on ClinicalTrials.gov: NCT01943474 ↗Enrolled (actual)
248
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: First Attempt Success Rate With Peripheral IV Catheter Placement — 89; 47 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AccuCath IV Catheter Device (Device); Conventional IV Catheter Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY First Attempt Success Rate With Peripheral IV Catheter Placement |
89; 47 | <0.0001 sig |
| SECONDARY Completion of IV Therapy |
89.4; 34.4 | <0.0001 sig |
| SECONDARY Complications of Peripheral IV Therapy |
8; 52 | <0.0001 sig |
| SECONDARY Catheter Dwell Time |
105; 35 | <0.0001 sig |
| SECONDARY Patient Satisfaction At Insertion |
4.6; 3.0 | <0.0001 sig |
| SECONDARY Clinician Satisfaction |
4 | — |
| SECONDARY Adverse Events |
2.4; 26.4; 0.8; 8.8; 0.8; 5.6 | — |
| SECONDARY Patient Satisfaction Comfort Comparison |
4.2; 2.86 | <0.0001 sig |
| SECONDARY Patient Satisfaction With Overall IV Performance |
4.84; 2.84 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female, age ≥ 18 years or ≤ 89 years old;
- Capable and willing to give informed consent;
- English speaking;
- Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
- Admitted to study inpatient unit.
Exclusion Criteria
- Male or female, 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 principal investigator [PI]);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
Data sourced from ClinicalTrials.gov (NCT01943474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.