N/A
N=95
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
Vascular Access Complication
Bottom Line
View on ClinicalTrials.gov: NCT01937195 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt — 85.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AccuCath Intravenous Catheter System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt |
85.3 | — |
| SECONDARY Percentage of Patients With Complications of Peripheral IV Therapy |
17.9 | — |
| SECONDARY Completion of IV Therapy |
78 | — |
| SECONDARY Catheter Dwell Time |
58 | — |
| SECONDARY Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion |
100.0 | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
17; 7; 6; 3; 1 | — |
| SECONDARY Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal |
97.9 | — |
Summary
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) 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 > or equal to 18 years or 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 PI);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
Data sourced from ClinicalTrials.gov (NCT01937195). 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.