N/A
Completed N=248
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
Vascular Access Complication
Source: ClinicalTrials.gov NCT01943474 ↗
Enrolled (actual)
248
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: First Attempt Success Rate With Peripheral IV Catheter Placement — 89; 47 percentage of participants — p=<0.0001
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.
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 |
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. Informational only — not medical advice.