AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use

NCT01943474 | Completed Results

• 1 other identifier: DDVP-001/VPW-STP-00004
• Study Type: interventional
• Target: 248
• 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 (IV) 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)

• 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.

  At catheter placement, an expected average of 10 minutes

Secondary Outcomes (8)

• Completion of IV Therapy

  Study exit/At catheter removal (~ up to 7 days)

• Complications of Peripheral IV Therapy

  From during to post IV catheter placement up to study exit (~ up to 7 days)

• Catheter Dwell Time

  Study Exit/At catheter removal (~ up to 7 days)

• Patient Satisfaction At Insertion

  At catheter insertion, initial 3-15 minutes after insertion procedure completed.

• Clinician Satisfaction

  At completion of study after all patients have been enrolled (approximately 6 months from study initiation)

Study Arms (2)

AccuCath IV Catheter Device

EXPERIMENTAL

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

Device: AccuCath IV Catheter Device

Conventional IV Catheter Device

ACTIVE COMPARATOR

Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal

Device: Conventional IV Catheter Device

Interventions

AccuCath IV Catheter Device DEVICE

Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.

Also known as: Rapid Intravascular Start System (RIVS), AccuCath System, AccuCath IV device, AccuCath, AccuCath PIV, AccuCath Short IV, AccuCath IV Catheter

AccuCath IV Catheter Device

Conventional IV Catheter Device DEVICE

Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.

Also known as: Insyte Autoguard, Insyte Autoguard PIV, Insyte Autoguard IV Catheter, Insyte Autoguard IV device

Conventional IV Catheter Device

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 ≥ 18 years or ≤ 89 years old;
• Capable and willing to give informed consent;
• English speaking;
• Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement 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 principal investigator \[PI\]);
• 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)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Results Point of Contact

• Title: Gina Gilbert
• Organization: C. R. Bard

gina.gilbert@crbard.com

407-489-0835

Study Officials

• James Rowbottom, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Bette Idemoto, PhD, RN

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: September 17, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)