AzTrials
AzTrials

Difficult Vein AccessSUMMITNCT07779317

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

A study testing Ultrasound-Guided Single-Lumen Midline Catheter and Ultrasound-Guided Long Peripheral Intravenous Catheter in people with Difficult Vein Access and Emergency Department Patients, run by Albany Medical College at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ultrasound-Guided Single-Lumen Midline Catheter and Ultrasound-Guided Long Peripheral Intravenous Catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
1 siteUnited States
Study dates
11 Aug 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 18Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Bracey, MD contact

518-262-6328

braceya@amc.edu

United States1 site, 1 recruiting
  • Albany Medical Center Hospital

    Albany, New York, 12208

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

    Recruiting

Other trials in United States

About this study

Official title: Superior Venous Access: Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses, A Randomized Clinical 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.

Read more

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.

Being tested
Ultrasound-Guided Single-Lumen Midline Catheter, Ultrasound-Guided Long Peripheral Intravenous Catheter
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
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Single-Lumen Midline CatheterDevice

    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 CatheterDevice

    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.

Study groups in NCT07779317
Study groupRoleWhat they receive
Ultrasound-Guided Single-Lumen Midline CatheterExperimentalParticipants 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.
Receives: Device: Ultrasound-Guided Single-Lumen Midline Catheter
Ultrasound-Guided Long Peripheral Intravenous CatheterActive comparatorParticipants 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.
Receives: Device: Ultrasound-Guided Long Peripheral Intravenous Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediately following the vascular access procedure.

Secondary outcomes (5)
  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.

    Measured: 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"

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: Immediately following successful insertion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start11 Aug 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants with difficult intravenous access will be randomized in a 1:1 ratio to undergo either ultrasound-guided single-lumen midline catheter insertion or ultrasound-guided long peripheral intravenous catheter insertion. All study procedures will be performed by trained bedside emergency department registered nurses.
Masking
None (open label)
Enrolment
292 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779317
Sponsor's protocol ID
7392
Other IDs
CyberGrant 100756295
Acronym
SUMMIT
Status last verified
Aug 2026
First submitted
15 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Single-Lumen Midline Catheter and Ultrasound-Guided Long Peripheral Intravenous Catheter in people with Difficult Vein Access and Emergency Department Patients, run by Albany Medical College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Bracey, MD (518-262-6328, braceya@amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Success of Ultrasound-Guided Vascular Access Device Insertion (time frame: Immediately following the vascular access procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07779317, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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