Midline Catheter vs Peripheral IV for Difficult Venous Access
(SUMMIT Trial)
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for catheter-related complications and procedural success, with assessments continuing through hospital discharge.
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.
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
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Albany Medical College
Lead Sponsor
Becton, Dickinson and Company
Industry Sponsor
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
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