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

NCT01937195 | Completed Results

• 1 other identifier: VPW-STP-00002
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt

  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.

  Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure

Secondary Outcomes (6)

• Percentage of Patients With Complications of Peripheral IV Therapy

  Study exit/at catheter removal expected to be up to 7 days post placement

• Completion of IV Therapy

  Study exit/at catheter removal expected to be up to 7 days post placement

• Catheter Dwell Time

  Study exit/at catheter removal expected to be up to 7 days post placement

• 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

• Number of Participants Experiencing Adverse Events

  baseline, and up to catheter removal expected to be no more than 7 days post placement

Study Arms (1)

AccuCath Intravenous Catheter System

EXPERIMENTAL

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

Device: AccuCath Intravenous Catheter System

Interventions

AccuCath Intravenous Catheter System 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.

AccuCath Intravenous Catheter System

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age \> or equal to 18 years or \< or equal to 89 years old;
• Capable and willing to give informed consent;
• English speaking;
• Acceptable candidate for an elective, non-emergent PIV as determined by ordering physician;
• Admitted to study inpatient unit.

You may not qualify if:

• Male or female, \< 18 years old or \> 89 years old;
• Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
• Previous venous grafts or surgery at the target vessel access site;
• Currently involved in other investigational clinical trials (unless permission is granted by other study PI);
• Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Evangelical Community Hospital

Lewisburg, Pennsylvania, 17837, United States

Location

Related Publications (1)

• 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.

  PMID: 27379678 RESULT

Results Point of Contact

• Title: Norman R. Anderson
• Organization: Evangelical Community Hospital

nanderson@evanhospital.com

570-222-2000

Study Officials

• Norman R Anderson, RN

  Evangelical Community Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: September 9, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)