ClinicalTrials.gg
RecruitingNCT07779317SUMMITUpdated Aug 25, 2026

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

An interventional study of Ultrasound-Guided Single-Lumen Midline Catheter and Ultrasound-Guided Long Peripheral Intravenous Catheter in Difficult Vein Access, Emergency Department Patients and Nurses Role, sponsored by Albany Medical College. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Albany Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
292
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Difficult Vein Access
  • Emergency Department Patients
  • Nurses Role
  • Midline Catheter
  • Ultrasound Assistance
  • Difficult Intravenous Access
  • Catheterization, Peripheral
  • Catheterization
  • Emergency Service, Hospital

Browse trials for

Keywords

  • DIVA
  • Ultrasound-Guided Vascular Access
  • Midline Catheter
  • Single-Lumen Midline Catheter
  • Long Peripheral Intravenous Catheter
  • Ultrasound-Guided Peripheral Intravenous Catheter
  • Emergency Department Nursing
  • Emergency Nursing
  • Vascular Access Device
  • Ultrasound-Guided Intravenous Access
03

In context

Lead sponsor

Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
292 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceUltrasound-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.

  • DeviceUltrasound-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.

06

What researchers measure

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)

  5. Catheter Length Within the Cannulated Vessel (Vein Purchase)

    Vein purchase will be defined as the length of the catheter residing within the successfully cannulated vessel

    Time frame: Immediately following successful insertion.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PubMed 18929686 ↗
  • Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964. PubMed 26398070 ↗
  • Donati A, Damiani E, Adrario E, Romano R, Pelaia P. Pain and discomfort management during central venous catheter insertion. Indian J Crit Care Med. 2014 Jul;18(7):417-8. doi: 10.4103/0972-5229.136066. No abstract available. PubMed 25097351 ↗
  • Flores BCT, Chawla S, Ma N, Sanada C, Kujur PK, Yeung R, Bellon MB, Hukari K, Fowler B, Lynch M, Chinen LTD, Ramalingam N, Sengupta D, Jeffrey SS. Microfluidic live tracking and transcriptomics of cancer-immune cell doublets link intercellular proximity and gene regulation. Commun Biol. 2022 Nov 12;5(1):1231. doi: 10.1038/s42003-022-04205-y. PubMed 36371461 ↗
  • Renner A, Stoshikj S, Pohl W, Bal C, Reisinger M, Loffler-Ragg J, Zacharasiewicz A, Buhl R, Hamelmann E, Taube C, Korn S, Idzko M. Characterization of Austrian severe asthma patients. Respir Med. 2023 Nov-Dec;219:107427. doi: 10.1016/j.rmed.2023.107427. Epub 2023 Oct 10. PubMed 37827294 ↗
  • Li S, Peng B, Wang S. Establishment of adsorption isotherms of m- and p-cresols in chromatographic process with aluminum terephthalate metal-organic framework as stationary phase. J Chromatogr A. 2020 Jan 25;1611:460599. doi: 10.1016/j.chroma.2019.460599. Epub 2019 Oct 4. PubMed 31623847 ↗
  • Prasanna N, Yamane D, Haridasa N, Davison D, Sparks A, Hawkins K. Safety and efficacy of vasopressor administration through midline catheters. J Crit Care. 2021 Feb;61:1-4. doi: 10.1016/j.jcrc.2020.09.024. Epub 2020 Oct 2. PubMed 33049486 ↗
  • Tripathi S, Kumar S, Kaushik S. The Practice and Complications of Midline Catheters: A Systematic Review. Crit Care Med. 2021 Feb 1;49(2):e140-e150. doi: 10.1097/CCM.0000000000004764. PubMed 33372744 ↗
  • Bahl A, Hang B, Brackney A, Joseph S, Karabon P, Mohammad A, Nnanabu I, Shotkin P. Standard long IV catheters versus extended dwell catheters: A randomized comparison of ultrasound-guided catheter survival. Am J Emerg Med. 2019 Apr;37(4):715-721. doi: 10.1016/j.ajem.2018.07.031. Epub 2018 Jul 19. PubMed 30037560 ↗
  • Adams DZ, Little A, Vinsant C, Khandelwal S. The Midline Catheter: A Clinical Review. J Emerg Med. 2016 Sep;51(3):252-8. doi: 10.1016/j.jemermed.2016.05.029. Epub 2016 Jul 5. PubMed 27397766 ↗
  • Elia F, Ferrari G, Molino P, Converso M, De Filippi G, Milan A, Apra F. Standard-length catheters vs long catheters in ultrasound-guided peripheral vein cannulation. Am J Emerg Med. 2012 Jun;30(5):712-6. doi: 10.1016/j.ajem.2011.04.019. Epub 2011 Jun 23. PubMed 21703801 ↗
  • Bahl A, Hijazi M, Chen NW, Lachapelle-Clavette L, Price J. Ultralong Versus Standard Long Peripheral Intravenous Catheters: A Randomized Controlled Trial of Ultrasonographically Guided Catheter Survival. Ann Emerg Med. 2020 Aug;76(2):134-142. doi: 10.1016/j.annemergmed.2019.11.013. Epub 2020 Jan 16. PubMed 31955940 ↗
  • Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8. PubMed 10577399 ↗
  • Chopra V, Flanders SA, Saint S, Woller SC, O'Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40. doi: 10.7326/M15-0744. PubMed 26369828 ↗
  • Shokoohi H, Loesche MA, Duggan NM, Liteplo AS, Huang C, Al Saud AA, McEvoy D, Liu SW, Dutta S. Difficult intravenous access as an independent predictor of delayed care and prolonged length of stay in the emergency department. J Am Coll Emerg Physicians Open. 2020 Aug 19;1(6):1660-1668. doi: 10.1002/emp2.12222. eCollection 2020 Dec. PubMed 33392574 ↗
  • Huang D, Winter L, Macauley E, Alterman T, Renouard B, Wilson JL, Leon LN. Difficult Intravenous Access Requiring Ultrasound in the Emergency Department: Associations With Delays in Care and Areas for Quality Improvement. Cureus. 2023 Sep 9;15(9):e44960. doi: 10.7759/cureus.44960. eCollection 2023 Sep. PubMed 37822433 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07779317
Lead sponsor
Albany Medical College
Responsible party
Alexander Bracey, MD (Associate Professor, Emergency Medicine, Albany Medical College) — Principal investigator
First posted
Aug 21, 2026
Start date
Aug 11, 2026
Primary completion
Jan 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Aug 25, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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