292 Participants NeededMy employer runs this trial

Midline Catheter vs Peripheral IV for Difficult Venous Access

(SUMMIT Trial)

AB
Overseen ByAlexander Bracey, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Albany Medical College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults in the emergency room who have trouble getting an IV started (difficult intravenous access). Participants must need IV access for their care and be able to receive either type of catheter. Specific inclusion or exclusion criteria are not detailed.

Inclusion Criteria

Have difficult intravenous access with a history of or active comorbid condition including sickle cell disease
Have difficult intravenous access with a history of or active comorbid condition including current or previous intravenous drug use
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
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Exclusion Criteria

Prisoners
Patients for whom the informed consent and enrollment process could delay time-sensitive medical care
Patients known to be pregnant
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either an ultrasound-guided single-lumen midline catheter or an ultrasound-guided long peripheral IV catheter, inserted by trained bedside emergency department nurses.

Immediate procedure
1 visit (in-person)

Follow-up

Participants are monitored for catheter-related complications and procedural success, with assessments continuing through hospital discharge.

Up to 30 days following hospitalization

Completion of Care

Completion of care is assessed by determining if the study device remains functional until hospital discharge or if intravenous access is no longer required.

Through hospital discharge, up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Ultrasound-Guided Long Peripheral Intravenous Catheter
  • Ultrasound-Guided Single-Lumen Midline Catheter

Trial Overview

The study compares two ways of starting IVs using ultrasound: a single-lumen midline catheter versus a long peripheral IV catheter, both placed by specially trained ER nurses. Patients are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ultrasound-Guided Single-Lumen Midline CatheterExperimental Treatment1 Intervention
Group II: Ultrasound-Guided Long Peripheral Intravenous CatheterActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials
96
Recruited
12,700+

Becton, Dickinson and Company

Industry Sponsor

Trials
80
Recruited
92,000+

Tom Polen

Becton, Dickinson and Company

Chief Executive Officer since 2020

Bachelor’s degree from Salisbury University, MBA from Johns Hopkins University

Meera Gopalakrishnan

Becton, Dickinson and Company

Chief Medical Officer

Ph.D. in Biomedical Engineering from the University of Memphis