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Recruiting NCT07779317

NCT07779317 Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses

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Clinical Trial Summary
NCT ID NCT07779317
Status Recruiting
Phase
Sponsor Albany Medical College
Condition Difficult Vein Access
Study Type INTERVENTIONAL
Enrollment 292 participants
Start Date 2026-08-11
Primary Completion 2027-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Ultrasound-Guided Single-Lumen Midline CatheterUltrasound-Guided Long Peripheral Intravenous Catheter

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 292 participants in total. It began in 2026-08-11 with a primary completion date of 2027-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

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

Contact & Investigator

Central Contact

Alexander Bracey, MD

✉ braceya@amc.edu

📞 518-262-6328

Frequently Asked Questions

Who can join the NCT07779317 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Difficult Vein Access. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07779317 currently recruiting?

Yes, NCT07779317 is actively recruiting participants. Contact the research team at braceya@amc.edu for enrollment information.

Where is the NCT07779317 trial being conducted?

This trial is being conducted at Albany, United States.

Who is sponsoring the NCT07779317 clinical trial?

NCT07779317 is sponsored by Albany Medical College. The trial plans to enroll 292 participants.

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