Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbany Medical College

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Single-Lumen Midline Catheter

    Device

    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.

  • Ultrasound-Guided Long Peripheral Intravenous Catheter

    Device

    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.

Treatment groups

292 Participants
are divided into 2 treatment groups
Group A: Ultrasound-Guided Single-Lumen Midline CatheterExperimental treatment 1 intervention
Group B: Ultrasound-Guided Long Peripheral Intravenous CatheterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately following the vascular access procedure.

Secondary outcomes

1

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.

Time frame
From device insertion through 30 days following hospitalization.
2

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"

Time frame
Immediately following study device insertion.
3

Catheter Dwell Time

Catheter dwell time will be defined as the time from successful device insertion until device removal or completion of care.

Time frame
From insertion until device removal or hospital discharge, assessed up to 100 months.
4

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.

Time frame
Through hospital discharge, (up to 1 year)

Other outcomes

Sponsors and contacts

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Albany Medical College

Lead sponsor

Becton, Dickinson and Company

Collaborator