RIVS (AccuCath Device) Versus (Conventional) PIV Catheter

Vascular Access Complication Clinical Trial

Official title:

A Prospective, Non-Blinded, Randomized Controlled, Study Designed to Evaluate User Preferences Associated With the Rapid Intravascular Start (RIVS/AccuCath) System Versus Conventional Catheters for Peripheral Intravenous (PIV) Access

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01943474
• Other study ID #: DDVP-001/VPW-STP-00004
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2013
• Last updated: September 11, 2013
• Start date: April 2013
• Est. completion date: October 2013

Study information

• Verified date: September 2013
• Source: Vascular Pathways, Inc.
• Contact: Bette Idemoto, PhD, RN
• Phone: 216-844-2202
• Email: bette.idemoto[@]uhhospitals.org
• 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 peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to Conventional IV Catheters.

Description:

This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device related vascular complications and adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to Conventional IV Catheters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 2013
• Est. primary completion date: October 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Access Complication

Intervention

Device:
• AccuCath IV Catheter Device
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
• Conventional IV Catheter Device
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

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 outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.	baseline/at catheter 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 (up to 7 days)	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 (up to 7 days)	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 (up to 7 days)	No
Secondary	Patient Satisfaction	Will survey patients regarding satisfaction with catheter insertion and overall performance during use of peripheral IV catheter.	Baseline at catheter insertion and study exit at catheter removal (up to 7 days)	No
Secondary	Clinician satisfaction	Will measure clinician satisfaction via a survey based on overall catheter performance during experience and use.	At end of study	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, during and study exit.	Yes