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

NCT ID: NCT01937195

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

Vascular Access Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AccuCath Intravenous Catheter System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norman R Anderson, RN

Role: PRINCIPAL_INVESTIGATOR

Evangelical Community Hospital

Locations

Evangelical Community Hospital

Lewisburg, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27379678 (View on PubMed)

Other Identifiers

VPW-STP-00002

Identifier Type: -

Identifier Source: org_study_id