Evaluating the Role of the Guidewire in Peripheral Intravenous Access

NCT ID: NCT04949854

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Peripheral Intravenous Vein Catheter Phlebitis; Intravenous Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control Arm B.Braun 6.35 cm 20 Gauge catheter

Device 6.35 cm 20 Gauge B. Braun catheter without guidewire

Group Type: ACTIVE_COMPARATOR

B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter

Intervention Type: DEVICE

control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire

Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter

Device BD 5.71 cm Accucath IV catheter with guidewire

Group Type: EXPERIMENTAL

B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter

Intervention Type: DEVICE

Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire

Interventions

B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter

control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Bahl, MD.

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Hospitals

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2021-049

Identifier Type: -

Identifier Source: org_study_id