AccuCath™ Intravenous Catheter System Compared to Conventional Peripheral Intravenous Catheters

Vascular Access Complication Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01937195
• Other study ID #: VPW-STP-00002
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2013
• Last updated: September 3, 2013
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: Vascular Pathways, Inc.
• Contact: Norman R Anderson, RN
• Phone: 5705222000
• Email: nanderson[@]evanhospital.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt PIV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to Conventional IV Catheters.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Device:
• AccuCath Intravenous Catheter System
AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.

Locations

Country	Name	City	State
United States	Evangelical Community Hospital	Lewisburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Pathways, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate with peripheral IV catheter placement	The primary endpoint is to observe first attempt success rate in patients requiring PIV access by documenting the number of catheter attempts (each new catheter) required to complete successful PIV placement.	Baseline/at catheter placement	No
Secondary	Complications of peripheral IV therapy	Will measure the rate of observed (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).	Study exit/at catheter removal expected to be no more than 7 days post placement	No
Secondary	Completion of IV therapy	Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (up to 7 days).	Study exit/at catheter removal expected to be no more than 7 days post placement	No
Secondary	Catheter dwell time	Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter)up to 7 days.	Study exit/at catheter removal expected to be no more than 7 days post placement	No
Secondary	Patient Satisfaction	Will survey patients regarding satisfaction with catheter insertion and at catheter removal regarding overall performance during use of peripheral IV catheter.	Baseline at catheter insertion and study exit at catheter removal expected to be no more than 7 days post placement	No
Secondary	Adverse events	Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups) up to 7 days.	baseline, and up to catheter removal expected to be no more than 7 days post placement	Yes
Secondary	Clinical Satisfaction	Will measure clinician satisfaction via a survey based on overall catheter performance during experience and use.	At completion of study - expected to be no more than 6 months from start	No