Evaluating the Role of the Guidewire in Peripheral Intravenous Access

Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival

This study is to demonstrate that the control ultralong intravenous catheter without the guide wire is equivalent to the experimental catheter with the guide wire. The hypothesis of this study is that the 6.35 cm 20G ultralong Ultrasound Guided Peripheral Intravenous (USPIV) will have no difference in survival compared to the 5.71 cm ultralong with wire USPIV.

Study Overview

• Status: Withdrawn
• Conditions: Peripheral Intravenous Vein Catheter Phlebitis; Intravenous Infection
• Intervention / Treatment: Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter; Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter

Detailed Description

Peripheral intravenous catheter (PIVC) insertion is a standard hospital procedure that enables providers to rapidly administer fluids, medications, or blood products directly into a patients vein. This allows patients who have difficulty with tolerating oral intake or patients who are being prepared for surgery to still receive the proper treatments. Furthermore, because many medications are not designed to be administered orally, a PIVC is often used.

Despite being a common procedure, PIVC insertion routinely fails with failure rates of traditional blind intravenous (IV) catheter placement ranging from 19%-29.9%. Common causes of failure include infiltration, occlusion, dislodgement, phlebitis, and infection. In addition to increasing costs, multiple placements of an IV catheter during a hospital stay places a considerable time burden on hospital staff. One effort to alleviate this burden has been the introduction of ultrasound, which is shown to help mitigate failure rates of PIVC placement in patients with difficult vascular access. .

The catheter length in vein is the single most relevant variable in determining catheter survival in USPIV insertions. IV Catheter survival depends on the length of the catheter inside the veins. Vein depth and angle of insertion play a significant role in choosing the right catheter length to achieve the ideal quantity of catheter in vein. When a shallow angle is used, the catheter distance to the vein also increases and longer catheters are needed to achieve the optimal 2.75 cm in vein. Unfortunately, the longest most commonly stocked peripheral IV catheter at most institutions is 4.78 cm. This length is inadequate for insertions with a vein depth of greater than approximately 0.75 cm. As this is a commonly encountered vein depth, longer peripheral IV catheters are needed to ensure improved catheter survival.Few peripheral intravenous catheter options exist with the Ultra Long profile. The 6.35 cm B. Braun deep access device and the BD 5.71 cm Accucath device are two commercially available options for this category of ultra long peripheral IVs. Both catheters are available and being used in Beaumont Hospital.The 6.35 cm option is similar to other peripheral IV catheters and is inserted using the same technique applied for all ultrasound guided IV insertions. The 5.71 cm option is similar to other peripheral IVs with the additional feature of a built-in wire within the device to help guide the catheter in the vein once the needle has penetrated the vein. The cost of the 5.71 cm option is approximately ten times the cost of the 6.35 cm device.

Adult patients with a Vascular Access Score of 4 or 5 (where Score 1= Visible with distention and easily palpable; Score 2=Visible and easily palpable; Score 3= Not visible and easily palpable; Score 4=Visible and poorly palpable and Score 5=Not visible and poorly or non-palpable) will be approached for inclusion in the study.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit Bahl, MD.; Phone Number: (248) 898-9111; Email: Amit.Bahl@beaumont.edu
• Study Contact Backup: Name: Diedre Brunk, RN, BSN, MBA; Phone Number: 248-898-5580; Email: Diedre.Brunk@beaumont.org

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Eligible patients must be:

1. ≥ than 18 years old
2. Vascular Access Score 4 or 5.

Clinicians Eligibility Criteria:

1. Clinician working in the emergency room (physician, advanced practice provider, nurse, technician) OR clinician working on the inpatient vascular access team (advanced practice provider, nurse)
2. Greater than 6 months experience in ultrasound guided IV insertions

Patients are excluded:

1. <18 years old
2. Restricted mobility of elbow joint
3. Cognitively impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm B.Braun 6.35 cm 20 Gauge catheter; Device 6.35 cm 20 Gauge B. Braun catheter without guidewire	Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter; control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire
Experimental: Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter; Device BD 5.71 cm Accucath IV catheter with guidewire	Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter; Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter survival	Survival in hours or days of the catheter will be evaluated by functionality of catheter for intravenous therapy prior to patient discharge. The event of interest is failure of functionality identified during follow-up assessment during hospitalization.	During hospitalization, up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-stick success.	Number of patients with only one puncture of skin to achieve venous access	First day of hospitalization
Time to insertion	Time to insertion (measured in minutes) is defined as needlestick to dressing application.	First day of hospitalization
Provider proficiency	Change in mean number of attempts per patient for successful insertion, from baseline mean for first three patients attempted to last three patients attempted.	Study period, a maximum of 1 year
Total cost for all vascular access needs during hospitalization.	Cost per patient for vascular access during hospitalization, comprising (i) direct costs of IV insertion based on estimated labor and material cost per insertion attempt and estimated similar costs for rescue devices if needed and (ii) cost of treatment based on estimated cost per hour.	During hospitalization, up to 60 days
Catheter-associated thrombosis	The number of patients with all symptomatic catheter related upper extremity venous thrombosis inclusive of superficial thrombophlebitis (SVT), deep venous thrombosis(DVT), and pulmonary embolism will be confirmed by upper extremity doppler evaluation, computed tomography, and/or ventilation perfusion testing.	During hospitalization, up to 60 days
Catheter-associated bloodstream infection	The number of patients with catheter-associated bloodstream infection. Cases of infection will be diagnosed per laboratory confirmed bloodstream infection criteria published by the National Healthcare Safety Network (NHSN) and identified by the Department of Epidemiology at Beaumont Hospital.	During hospitalization, up to 60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory complications by clinical assessment	Number of patients with inflammatory complications measured by a score of 2 or greater on a standardized visual phlebitis scale, with a range of 0 to 5 where 0 is no inflammation and 5 is advanced stage thrombophlebitis.	During hospitalization, up to 60 days

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Amit Bahl, MD., William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Phlebitis; PIV; BBraun Ultra Long Catheter; BD Accucath; IV Infection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis; Peripheral Vascular Diseases; Phlebitis
• Other Study ID Numbers: 2021-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes