Superior Venous Access: Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses, A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Procedural Success of Ultrasound-Guided Vascular Access Device Insertion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ultrasound-Guided Single-Lumen Midline Catheter (Device)
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.
干预措施: Ultrasound-Guided Long Peripheral Intravenous Catheter (Device)
结局指标
主要结局
Procedural Success of Ultrasound-Guided Vascular Access Device Insertion
时间窗: Immediately following the vascular access procedure.
Procedural success will be defined as successful insertion of the study device into an ultrasound-identified target vessel with the ability to aspirate blood and flush saline without evidence of infiltration.
次要结局
- Catheter-Related Complications(From device insertion through 30 days following hospitalization.)
- Patient Satisfaction With Vascular Access Device(Immediately following study device insertion.)
- Catheter Dwell Time(From insertion until device removal or hospital discharge, assessed up to 100 months.)
- Catheter Length Within the Cannulated Vessel (Vein Purchase)(Immediately following successful insertion.)
- Completion of Care Using the Original Study Device(Through hospital discharge, (up to 1 year))
研究者
Alexander Bracey, MD
Associate Professor, Emergency Medicine
Albany Medical College
