Purpose

Obtaining intravenous (IV) access is one of the most common procedures performed in the emergency department (ED). IV access is necessary for many aspects of patient care, including blood tests, administration of medications and intravenous fluids, and diagnostic imaging. However, some patients have difficult intravenous access (DIVA), making it challenging to successfully place an IV catheter. Difficulty obtaining IV access can lead to delays in diagnosis and treatment, prolonged emergency department stays, multiple needle punctures, and increased patient discomfort. Several specialized IV devices are available for patients with DIVA. Two commonly used ultrasound-guided devices are long peripheral intravenous catheters and single-lumen midline catheters. Both devices are inserted into veins using ultrasound guidance, but they differ in catheter length and expected duration of use. Long peripheral IV catheters are commonly used in emergency departments but may fail relatively quickly. Midline catheters may remain functional for longer periods and may reduce the need for additional IV insertions during a patient's hospital stay. However, these devices have traditionally been inserted by specialized clinicians, such as members of vascular access teams, rather than by bedside emergency department nurses, who perform most vascular access procedures in many emergency departments. The purpose of this study is to compare ultrasound-guided single-lumen midline catheters with ultrasound-guided long peripheral IV catheters when both procedures are performed by specially trained bedside emergency department nurses. The study will evaluate whether midline catheters can be inserted as successfully and as safely as long peripheral IV catheters in adult emergency department patients with difficult intravenous access. Participants will be randomly assigned to receive either an ultrasound-guided single-lumen midline catheter or an ultrasound-guided long peripheral IV catheter. Researchers will compare the two devices by measuring procedural success, catheter-related complications, catheter dwell time, completion of care using the original device, and patient satisfaction. The results of this study may help determine whether bedside emergency department nurses with training and experience in ultrasound-guided vascular access can successfully use single-lumen midline catheters in routine clinical practice. The study will also evaluate which vascular access device provides the best balance of safety, reliability, and patient experience for emergency department patients with difficult intravenous access. This information may help guide future recommendations for vascular access device selection in the emergency department.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults 18 years of age or older - Presenting to the Albany Medical Center Emergency Department - Require intravenous access - Have difficult intravenous access (DIVA) defined by at least one of the following: - Two failed attempts at landmark-based or ultrasound-guided peripheral vascular access performed by qualified emergency department staff - A history of or active comorbid condition associated with difficult intravenous access, including: - Implanted vascular access port (current or previous) - End-stage renal disease with dialysis fistula - Sickle cell disease - Current or previous intravenous drug use - Self-reported difficult intravenous access plus one of the following: - A history of requiring two or more IV attempts during a previous healthcare encounter (self-reported or documented in the medical record) - A previous requirement for a rescue vascular access device after failed IV access, including: - Ultrasound-guided peripheral IV - Midline catheter - Peripherally inserted central catheter (PICC) - Central venous catheter (CVC) - Intraosseous catheter

Exclusion Criteria

  • Younger than 18 years of age - Prisoners - Non-English-proficient patients - Patients in whom the device cannot be adequately stabilized because of tissue injury or treatment involving the available extremities (including burns, complex humeral fractures, or dialysis fistulas) - Patients who lack the capacity to provide informed consent and do not have an authorized legal representative available - Patients without an identifiable target vein on ultrasonography - Patients known to be pregnant - Previous enrollment in the study - Previous withdrawal from the study - Presentation during a period when no study proceduralists are available - Patients for whom the informed consent and enrollment process could delay time-sensitive medical care

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants with difficult intravenous access will be randomized in a 1:1 ratio to undergo either ultrasound-guided single-lumen midline catheter insertion or ultrasound-guided long peripheral intravenous catheter insertion. All study procedures will be performed by trained bedside emergency department registered nurses.
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Masking will not be used because the two vascular access devices are visibly different, and neither participants nor investigators can be blinded to the intervention.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ultrasound-Guided Single-Lumen Midline Catheter
Participants randomized to this arm will undergo insertion of an ultrasound-guided single-lumen midline catheter performed by a trained bedside emergency department registered nurse. The proceduralist will select the catheter gauge and insertion site according to institutional practice.
  • Device: Ultrasound-Guided Single-Lumen Midline Catheter
    A BD PowerGlide™ 10-cm single-lumen midline catheter (18G or 20G) will be inserted under ultrasound guidance using standard institutional procedures. The catheter may be placed in the cephalic, basilic, deep brachial, or forearm veins according to proceduralist judgment.
Active Comparator
Ultrasound-Guided Long Peripheral Intravenous Catheter
Participants randomized to this arm will undergo insertion of an ultrasound-guided long peripheral intravenous catheter performed by a trained bedside emergency department registered nurse. The proceduralist will select the catheter gauge and insertion site according to institutional practice.
  • Device: Ultrasound-Guided Long Peripheral Intravenous Catheter
    A BD Insyte™ Autoguard 4.78-cm peripheral intravenous catheter (18G or 20G) will be inserted under ultrasound guidance using standard institutional procedures. The catheter may be placed in the cephalic, basilic, deep brachial, or forearm veins according to proceduralist judgment.

Recruiting Locations

Albany Medical Center Hospital
Albany, New York 12208
Contact:
Alexander Bracey, MD
518-262-6328
braceya@amc.edu

More Details

Status
Recruiting
Sponsor
Albany Medical College

Study Contact

Alexander Bracey, MD
518-262-6328
braceya@amc.edu

Detailed Description

Intravenous (IV) access is one of the most frequently performed procedures in emergency medicine and serves as the foundation for many aspects of acute patient care. Reliable vascular access is necessary for laboratory testing, administration of medications and intravenous fluids, contrast-enhanced imaging, blood product transfusion, and other diagnostic and therapeutic interventions. Failure to obtain timely IV access may delay treatment and contribute to prolonged emergency department (ED) length of stay. Difficult intravenous access (DIVA) has been identified as an independent predictor of delayed care and prolonged ED length of stay, making it an important operational and patient safety concern in emergency medicine. Previous studies have suggested that approximately 10% of ED patients have DIVA, while observational data from Albany Medical Center have demonstrated similar rates. Patients with DIVA frequently require multiple attempts at vascular access, which may increase patient discomfort, disrupt clinical workflow, and increase healthcare resource utilization. Numerous vascular access devices (VADs) are available to manage patients with DIVA. These devices differ in catheter length, insertion technique, location within the vascular system, expected dwell time, and clinical indications. Unlike inpatient settings, where guidance exists for selecting appropriate vascular access devices, there are currently no widely accepted recommendations for vascular access device selection in emergency department patients. Consequently, clinicians often rely on individual experience, local practice patterns, and device availability when selecting a vascular access strategy. Ultrasound-guided peripheral intravenous catheters are commonly used when traditional landmark-based IV insertion is unsuccessful. Previous investigations have demonstrated that catheter length influences device survival. Shorter catheters placed into deeper veins under ultrasound guidance are associated with shorter dwell times and earlier failure. Prior studies have demonstrated that ultrasound-guided long peripheral IV catheters may fail within hours of insertion and that increasing catheter length may improve catheter survival. These findings suggest that catheter design and insertion technique may play important roles in determining catheter performance. Single-lumen midline catheters (SLMCs) have emerged as an alternative vascular access device for patients who require intermediate-duration intravenous therapy. Midline catheters are inserted into peripheral veins of the upper extremity and terminate within the axillary venous system. Unlike central venous catheters, midline catheters remain entirely within the peripheral venous system while offering a longer catheter length than traditional peripheral IV catheters. Most midline catheters are inserted under ultrasound guidance and frequently incorporate modified or accelerated Seldinger techniques that may facilitate successful cannulation of deeper veins. Several characteristics make SLMCs attractive for the management of patients with DIVA. First, previous studies have suggested that midline catheters have substantially longer dwell times than peripheral IV catheters. Published investigations have reported average dwell times of approximately 16 days for midline catheters compared with approximately 5 days for peripheral IV catheters. Second, midline catheters may provide more durable vascular access throughout a patient's hospitalization. Previous studies have demonstrated that many patients who receive a midline catheter do not require any additional vascular access devices during the remainder of their hospital stay. These findings suggest that midline catheters may reduce the need for repeated vascular access procedures after initial insertion. However, relatively little evidence exists regarding the use of these devices in emergency department populations. Investigators at Albany Medical Center have conducted multiple studies evaluating advanced vascular access in emergency department patients. An ongoing observational study examining vascular access patterns in ED patients demonstrated that patients requiring advanced vascular access devices were generally older, had greater illness severity, and were more likely to arrive by ambulance. A pilot study evaluating procedural characteristics of advanced vascular access devices demonstrated differences in procedural duration and catheter dwell time among ultrasound-guided peripheral IV catheters, single-lumen midline catheters, and central venous catheters. Additional simulation-based work has been performed to characterize procedural workflows, identify procedural micro-skills, and develop standardized training strategies for advanced vascular access procedures. These investigations have provided important preliminary data regarding procedural performance and training requirements. The most relevant preliminary data informing the current study originate from an ongoing randomized controlled trial comparing SLMCs and ultrasound-guided long peripheral IV catheters in ED patients with DIVA. Preliminary analyses have demonstrated significantly longer catheter dwell times among patients receiving SLMCs. Furthermore, patients randomized to SLMCs experienced higher rates of vascular access remaining functional until completion of care and lower rates of catheter removal because of dislodgement, occlusion, or infiltration. These findings suggest that SLMCs may provide more reliable vascular access for patients with DIVA. Despite these encouraging findings, an important limitation of previous studies is the identity of the proceduralist. Existing studies evaluating SLMCs have generally involved emergency physicians, advanced practice providers, dedicated vascular access teams, or specialized vascular access nurses. In many emergency departments, however, bedside registered nurses are responsible for obtaining vascular access. As a result, the generalizability of previous findings remains uncertain. Demonstrating favorable outcomes in a controlled environment involving specialized operators does not necessarily establish that similar outcomes can be achieved when the procedure is performed by clinicians who provide routine bedside care in a busy emergency department. The current study was designed to address this implementation gap by evaluating the performance of SLMCs and ultrasound-guided long peripheral IV catheters when inserted by trained bedside emergency department nurses. Rather than evaluating the technical performance of the devices alone, the study examines whether a model of nurse-performed ultrasound-guided midline catheter insertion can be successfully integrated into routine emergency department practice. This distinction is important because bedside nurses perform most vascular access procedures in many emergency departments and may represent the clinicians most likely to adopt this technique if it proves to be effective. This prospective, randomized clinical trial will compare ultrasound-guided SLMCs and ultrasound-guided long peripheral IV catheters among adult emergency department patients with DIVA. Both devices will be inserted by bedside emergency department nurses who have undergone standardized training in ultrasound-guided vascular access techniques. The study will evaluate device performance across multiple domains, including procedural success, safety, catheter functionality, durability, and patient-centered outcomes. Additional exploratory analyses will examine the relationships among vessel characteristics, catheter position within the target vessel, and vascular access outcomes. The investigators hypothesize that ultrasound-guided SLMCs inserted by trained bedside emergency department nurses will demonstrate procedural success rates that are not inferior to ultrasound-guided long peripheral IV catheters while providing improved catheter durability and higher rates of completion of care. If these hypotheses are confirmed, the findings may support broader implementation of nurse-performed ultrasound-guided midline catheter insertion in emergency departments and may contribute to the development of future recommendations for vascular access device selection in patients with difficult intravenous access. This study may also provide insight into how emergency departments can expand advanced vascular access capabilities while minimizing repeated IV insertion attempts and improving the patient experience. Ultimately, the results may help define the role of bedside emergency department nurses in the delivery of advanced vascular access and identify strategies to improve the care of patients with difficult intravenous access.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.