Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the ED

Intravenous (IV) access is among the most commonly performed procedures performed in the acute care setting. IV access is also essential for the delivery critical care in the emergency department (ED) setting, as it allows for the collection of blood samples that can be sent for serum laboratory studies and the administration of medications, several of which are potentially lifesaving. While this procedure is common, achieving IV access may be challenging with prior work demonstrating that 1 in 9 patients may be considered to have difficult IV access in the ED setting. These patients may have delays in delivery of care leading to potential increased risk of morbidity and mortality.

There are many vascular access devices (VADs), each of which has different characteristics. For example, traditional IVs are typically 3-cm in length, while "long" and "ultralong" IVs are 4.78-cm and 6.35-cm respectively, with shorter catheters most often reserved for landmark based peripheral IV (PIV) placement while longer PIVs are used for deeper vessels with US guidance. It has been demonstrated that shorter IV catheters placed in deeper vessels under ultrasound (US) guidance have significantly shorter dwell times (duration before failure) than those with longer catheter length. One study demonstrated an IV failure rate of 8% within the first hour when using long 4.78-cm IV for deep vessels under US guidance. Another study of patients undergoing US guided IV insertion with an "ultralong" 6.35-cm PIV catheter versus "standard long" 4.78-cm PIV reported a median dwell time of 136 hours and 96 hours respectively. Furthermore, 12-cm PIVs inserted using Seldinger technique have been shown to have a longer mean dwell time. Another study demonstrated a mean dwell time of 6.2 days in 12-cm, US-guided, Seldinger-technique PIVs compared to the 3.5 days with a 5 cm, US-guided, non-Seldinger-technique PIV. Therefore, it is reasonable to assume that catheter length has a direct influence on catheter dwell time.

An especially promising area of longer IVs is in the administration of medications that are used to artificially elevate blood pressure (e.g., vasopressors). Traditionally such medications are administered through central venous access via a central venous catheter (CVC). This practice was born out of fear of vasopressor extravasation from peripheral administration that could result in tissue necrosis and/or limb ischemia. Such reports, however, are based on older case reports while recent robust literature indicates that such events are fleetingly rare.

There is burgeoning literature supporting the use of midline catheters (MCs) for those patients requiring intermediate duration of IV access and who may have difficult IV access. MCs are a heterogenous group of VADs that may be single or dual lumen and may feature fixed or trimmable catheters. MCs are almost exclusively placed using ultrasound guidance and can be placed rapidly as many feature quick or accelerated Seldinger technique (i.e., needle into vein, wire through needle, needle removed, catheter over wire, and finally wire removed with all steps occurring within a single device). Seldinger technique is a widely established technique for IV catheters inserted into the central venous system and may confer benefit when accessing peripheral veins as well.

MCs may have advantages over PIVs for the management of critically ill patients in the ED setting for at least three reasons. First, despite the heterogeneity in length, gauge, and insertion technique, MCs are categorically more reliable than PIVs with existing studies showing average dwell times of 16.3 days for MC versus 4.8 days for PIVs. Second, MCs can serve as long term vascular access, with one study demonstrating that 68% of patients who underwent MC placement never required additional IV insertion through the remainder of their hospitalization. Third, some MCs are capable of providing multiple ports of access at a single site, which is helpful when needing to infuse several medications simultaneously as is common in the management of critically ill patients.

While it has been demonstrated that increasing PIV catheter lengths are associated with increased duration of PIV dwell times, it is not known whether MCs confer benefit, such as increased dwell time, over long PIVs. In addition, there is at least the perception MCs take longer to place than PIVs. Finally, it is largely unknown whether patient or provider preferences differ for each type of line. Therefore, in order to answer these questions, the investigators intend to perform a randomized clinical trial of ultrasound-guided long PIVs versus ultrasound-guided MCs in the ED patients with difficult IV access.

Importantly, both ultrasound-guided MCs and ultrasound-guided PIVs are approved for standard of care (SOC) use at Albany Medical Center (AMC) for patient care.

Specific Aims

Aim 1: To determine if US-guided MCs (10-cm) have longer dwell times (a longer duration before failure) than US-guided long PIVs (4.78-cm).

There are several reasons why long PIVs may fail. Long PIVs (4.78-cm) are shorter than MCs (10 cm), and shorter catheters may fail due to dislodgement out of the vein which can be a result of malposition as well as displacement during routine clinical course. Other common reasons for failure include pain, infiltration (i.e., when fluid leaks into the surrounding tissues rather than entering the blood stream), device leakage, device kinking, catheter occlusion, or phlebitis (i.e., painful inflammation after IV insertion). The investigators suspect that longer MCs (10-cm) placed with a guidewire (i.e., Seldinger technique) will confer benefit in the form of increased catheter dwell time and thus lower rates of failure when compared to long PIVs (4.78-cm).

Aim 2: To compare the complication rates of MCs (10-cm) versus long PIVs (4.78-cm) in ED patients with difficult IV access.

This is an exploratory analysis aimed at investigating complication rates of MCs vs long PIVs. Complications include but are not limited to the following: displacement, extravasation, arterial puncture, infection, deep vein thrombus, failure to aspirate, and multiple IV insertion attempts.

Aim 3: To determine patient experience, satisfaction, and preference; provider perceptions and cognitive load; and operational characteristics for each device placement.

Patient experience as measured by pain score, satisfaction, and preference will be determined based on an administered survey. The investigators theorize that a higher failure rate of long PIVs (4.78-cm) may lead to additional needle sticks for re-catheterization, resulting in patients preferring the more durable midline catheter to avoid additional needle sticks despite MC (10-cm) placement being marginally more invasive. Provider cognitive load and time to placement will be measured by a provider questionnaire and time-motion analysis. The investigators theorize that the cognitive load and time to placement will be equivalent in both arms. In addition, the investigators will record operational characteristics of the device placement and use including the number of catheters used for vascular access attempts, the time required for placement of each device, vascular access used for CT scanning, vascular access used for vasopressor administration, need for additional IV access during ED visit (MC, PIV, or central venous catheter (CVC)), catheter occlusion, and need for additional IVs during hospitalization. The investigators will also record patient arm circumference, and catheter length within the vessel to determine if these factors influence catheter dwell time.

This is a single center, prospective, 2-arm, nonblinded, randomized clinical trial to determine if MCs (10 cm) are superior to the long PIVs (4.78-cm) with respect to dwell time, dislodgement and infiltration rates, and patient preference. This study will be entered into clinicaltrials.gov.

Approval of this protocol from other departments is unnecessary because (a) the interventions of the study will be done in the ED setting \[with only observations of study participants being done on the medical and surgical floors\] and (b) all interventions are considered standard of care. Moreover, nursing research committee approval is not necessary because (a) all study procedures will be done by study personnel, (b) all interventions are considered standard of care, and (c) and nurses will not be asked to perform any additional tasks.

Randomization

Prior to the initiation of the study, the investigators will use an online randomizer to create a set of integers, 1 or 2.

https://ctrandomization.cancer.gov/tool/

"1" will be considered "long PIV" while "2" will be considered "single lumen midline catheter." The investigators will generate enough for twice the sample size (see below) with 30 extra to account for possible withdrawal or incomplete data, totaling 270 numbers generated. The investigators will then print these numbers along with the description (i.e., Long PIV or Single lumen midline catheter) on an individual sheet of paper which will be folded and then inserted into opaque envelopes that will then be sealed and only opened after written informed consent has been signed.. These envelopes will be stored under lock and key in the research office in the order in which randomization occurred.

Only after determining eligibility and obtaining consent will research personnel open the next consecutively numbered envelope, taking from the top of the stack. In this way, randomization to either long PIV or single lumen midline catheter will occur in a 1:1 ratio.

Study Devices

Four possible catheters will be used in this comparison: standard long 18- or 20- gauge BD Insyte Autoguard 4.78-cm IV catheters and single lumen 18- or 20-gauge BD Powerglide 10-cm midline catheter. Only 2 different lengths of catheters will be studied, each of which has two different gauge sizes (i.e., circumference). Gauge size will be determined by clinician preference which has no influence on medication administration. Both interventions are considered standard of care in our ED. Device insertion will be performed in the AMC ED. The study devices will be prepared in equipment bundles as below:

Note. While the study devices are long PIVs (4.78-cm) and MCs (10-cm); in the informed consent, the investigators will call these 2 inch and 4 inch for better understanding from the participants.

Equipment Bundles

Pre-prepared bundles will be available following randomization. These kits will be created by the research staff and kept in the research office. Kits will be composed of:

Long PIV Bundle:

* 18-gauge 4.78 cm BD Insyte Autoguard x1 * 20-gauge 4.78 cm BD Insyte Autoguard x1 * Sterile probe cover x1 * Sterile gel packet x1 * J-loop tubing x1 * Saline flush x1 * Sorbaview® transparent dressing and securement device x1 * Chlorhexidine swab x1

MC Bundle:

* 18-gauge 10 cm BD Powerglide Midline Catheter x1 * 20-guage 10 cm BD Powerglide Midline Catheter x1 * Sterile probe cover x1 * Sterile gel packet x1 * J-loop tubing x1 * Saline flush x1 * Statlock® securement device x1 * Transparent dressing x1 * Chlorhexidine swab x1

Study Arms

Patients who sign written informed consent will be randomized into one of two arms: long PIVs or single lumen MCs. Qualified proceduralists (Registered Nurses \[RNs\], Advanced Practice Provider \[APPs\], or physicians, all of whom are study team members) who have undergone formal training will perform device insertion in the AMC ED following randomization. MCs and long PIVs are both approved for use and stocked in the AMC ED.

Long PIV arm The BD Insyte Autoguard 4.78 cm 18- or 20-gauge needle with self-retraction is currently approved for use by the FDA and by Albany Medical center. The long PIV will be placed using standard aseptic technique (e.g., chlorhexidine prep, sterile gloves, sterile ultrasound probe cover

• Complication Rates [Срок оценки: through study completion, an average of 2 months.]
• Patient experience, satisfaction, and preference [Срок оценки: At the time of patient enrollment]
• Procedural Time [Срок оценки: At the time of patient enrollment]
• 3- and 5-day dwell time [Срок оценки: From enrollment through time to vascular access device removal, up to 28 days]
• Procdural Time [Срок оценки: At enrollment through device insertion, up to 2 hours]