Clinical trial NCT01937195: AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
Official title: A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters With a Vascular Access Team
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: 2013-09-09
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.

Detailed description: Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.

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 PIV 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 PI);
5. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

Primary outcomes:
measure: Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt
timeFrame: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure
Secondary outcomes:
measure: Percentage of Patients With Complications of Peripheral IV Therapy
timeFrame: Study exit/at catheter removal expected to be up to 7 days post placement
measure: Completion of IV Therapy
timeFrame: Study exit/at catheter removal expected to be up to 7 days post placement
measure: Catheter Dwell Time
timeFrame: Study exit/at catheter removal expected to be up to 7 days post placement
measure: Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion
timeFrame: Baseline at catheter insertion in the first 3-15 minutes after procedure
measure: Number of Participants Experiencing Adverse Events
timeFrame: baseline, and up to catheter removal expected to be no more than 7 days post placement
measure: Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal
timeFrame: At catheter removal, which is expected to be up to 7 days post placement
Other outcomes:
Locations:
city: Lewisburg
country: United States
facility: Evangelical Community Hospital
state: Pennsylvania
Study officials:
affiliation: Evangelical Community Hospital
name: Norman R Anderson, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson NR. Influencing Patient Satisfaction Scores: Prospective One-Arm Study of a Novel Intravenous Catheter System With Retractable Coiled-Tip Guidewire Compared With Published Literature for Conventional Peripheral Intravenous Catheters. J Infus Nurs. 2016 Jul-Aug;39(4):201-9. doi: 10.1097/NAN.0000000000000173.