AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)

Not Applicable

Completed

• Conditions: Vascular Access Complication
• Interventions: Device: AccuCath Intravenous Catheter System

• Registration Number: NCT01937195
• Lead Sponsor: C. R. Bard

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-09
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Results First Submitted: 2015-05-16
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Results First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AccuCath Intravenous Catheter System	AccuCath Intravenous Catheter System	AccuCath Intravenous Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt	Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure	The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Complications of Peripheral IV Therapy	Study exit/at catheter removal expected to be up to 7 days post placement	Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).
Completion of IV Therapy	Study exit/at catheter removal expected to be up to 7 days post placement	Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).
Catheter Dwell Time	Study exit/at catheter removal expected to be up to 7 days post placement	Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion	Baseline at catheter insertion in the first 3-15 minutes after procedure	Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Number of Participants Experiencing Adverse Events	baseline, and up to catheter removal expected to be no more than 7 days post placement	Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal	At catheter removal, which is expected to be up to 7 days post placement	Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.

Trial Locations

Locations (1)

Evangelical Community Hospital; 🇺🇸 Lewisburg, Pennsylvania, United States