About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 18 years of age or older
Presenting to the Albany Medical Center Emergency Department
Require intravenous access
Two failed attempts at landmark-based or ultrasound-guided peripheral vascular access performed by qualified emergency department staff
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Ultrasound-Guided Single-Lumen Midline Catheter
DeviceA 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.
Ultrasound-Guided Long Peripheral Intravenous Catheter
DeviceA 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.
Treatment groups
Trial outcomes
Primary outcomes
Procedural Success of Ultrasound-Guided Vascular Access Device Insertion
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.
Secondary outcomes
Catheter-Related Complications
Complications will include displacement, extravasation, arterial puncture, infection, deep vein thrombosis, failure to aspirate, and multiple IV insertion attempts. Complication data will be collected through medical record review and clinical assessment.
Patient Satisfaction With Vascular Access Device
Patient discomfort will be assessed using a questionnaire administered after study device insertion. "no discomfort, mild discomfort, moderate discomfort, severe discomfort, extreme discomfort"
Catheter Dwell Time
Catheter dwell time will be defined as the time from successful device insertion until device removal or completion of care.
Completion of Care Using the Original Study Device
Completion of care will be defined as the number of patients with a functional study device at hospital discharge or documentation that intravenous access was no longer required.
Sponsors and contacts
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Albany Medical College
Lead sponsor
Becton, Dickinson and Company
Collaborator