Clinical trial NCT04949854: Evaluating the Role of the Guidewire in Peripheral Intravenous Access
Official title: Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peripheral Intravenous Vein Catheter Phlebitis
Intravenous Infection
Keywords: PIV
BBraun Ultra Long Catheter
BD Accucath
Phlebitis
IV Infection
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm).
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Catheter survival
timeFrame: During hospitalization, up to 60 days
Secondary outcomes:
measure: First-stick success.
timeFrame: First day of hospitalization
measure: Time to insertion
timeFrame: First day of hospitalization
measure: Provider proficiency
timeFrame: Study period, a maximum of 1 year
measure: Total cost for all vascular access needs during hospitalization.
timeFrame: During hospitalization, up to 60 days
measure: Catheter-associated thrombosis
timeFrame: During hospitalization, up to 60 days
measure: Catheter-associated bloodstream infection
timeFrame: During hospitalization, up to 60 days
Other outcomes:
measure: Inflammatory complications by clinical assessment
timeFrame: During hospitalization, up to 60 days
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospitals
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Amit Bahl, MD.
role: PRINCIPAL_INVESTIGATOR
References: