NCT06668766 · Albany Medical College
Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the ED
What this study is about
Many patients in the emergency department have veins that are difficult to get an intrevenous (IV) catheter into (called "difficult IV access"). These patients may require other methods to obtain access to a vein for administration of the necessary medications. The 2-inch long IV is most commonly used in emergency departments for people with difficulty IV access.
View original scientific description
Many patients in the emergency department have veins that are difficult to get an intrevenous (IV) catheter into (called "difficult IV access"). These patients may require other methods to obtain access to a vein for administration of the necessary medications. The 2-inch long IV is most commonly used in emergency departments for people with difficulty IV access. Typically, a healthcare worker will use an ultrasound to help to see the veins underneath the skin while inserting the IV into the vein. That is, the ultrasound helps the healthcare worker visualize veins that are deeper in the arm and may not be felt through the skin. Another device that can be used is a 4-inch midline catheter. This device is less commonly used as many emergency departments do not have participants available, but it serves the same purpose as the 2-inch long IVs (that is, to give medicine into the vein and sometimes to take blood). A 4-inch midline catheter is similar to a 2-inch long IV, but has a few differences. First, the 4-inch midline catheter is even longer than the 2-inch long IV. The 4-inch midline catheter is 10-cm (about 4-inches or the size of 4 quarters side-by-side), while the 2-inch long IV is 4.78-cm (nearly 2-inches or two quarters side-by-side). Second, the 4-inch midline catheter is inserted into using a guidewire to help move the catheter in the vein (similar in concept to a train moving along a track), while the 2-inch long IV does not have this guidewire. The guidewire does not hurt and most do not know it is being used. It is just an additional step to help guide the catheter in the vein. The investigators are conducting this research study to determine which catheter is better for patients with difficult IV access: the 4-inch midline catheter or the 2-inch long IV.
Interventions
DEVICE
10-cm Single Lumen Mildine
Arm Description: The BD Powerglide Pro Midline catheter is currently approved for use by the FDA and by Albany Medical Center. This 18-gauge or 20-guage MC is distinct in that it is a standard 10-cm, does not require premeasurement or trimming of the catheter prior to placement, and features an accelerated Seldinger technique, meaning that it has a built-in deployable internal wire system. Additionally, because it is only 10-cm, it does not require a confirmatory chest x-ray prior to use. The provider will use standard aseptic technique for placing the MC (e.g., chlorhexidine prep, sterile probe cover and gel). Once the target vessel is identified, an ultrasound image of the vessel will be captured and recorded with the subject's study ID number from the randomization packet to allow for vessel depth and size measurement.
DEVICE
4.78 cm Long Peripheral Intravenous Catheter
The BD Insyte Autoguard 4.78 cm 18- or 20-gauge needle with self-retraction is currently approved for use by the FDA and by Albany Medical center. The long PIV will be placed using standard aseptic technique (e.g., chlorhexidine prep, sterile gloves, sterile ultrasound probe cover and gel). Once the target vessel is identified, an ultrasound image of the vessel will be captured and recorded with the subject's study ID number in the comments section of the QPATH worksheet to allow for vessel depth and size measurement. Operators will be instructed to use standard techniques in US-guided vascular access.
Primary outcome measures
Completion of Care and catheter dwell time
Time frame: From enrollment through time to vascular access device removal, up to 28 days
Catheter dwell time until completion of care will be measured. Completion of care will be considered to be the time of insertion of the study VAD to either a) discharge from the hospital or b) a documented completion of need for IV therapy warranting removal of the study VAD. Overall catheter survival will be determined by how long the catheter is in place and functional. We will report data based on a Kaplan Meier curve to display catheter survival.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult (age 18 and older) patients presenting to the AMC ED with difficult IV access defined as any of the following:
- Two failed attempts at landmark based IV or US-guided peripheral vascular access by qualified ED staff
- Self-reported history of difficult IV access and one of the following:
- History of requiring 2 or more IV attempts on a previous visit (either self-reported or documented in the electronic medical record)
- Previous requirement for a rescue device after failed IV access attempt. These devices are as follows:
- US guided PIV
- Midline catheter
- Peripherally inserted central catheter
- Central venous catheter
- Intraosseous catheter
- History of or active comorbid disease state with known difficult IV access
- Prior or current implanted port device
- End stage renal disease with fistula
- Sickle cell disease
- History of or active intravenous drug use
Exclusion criteria
- Patients under the age of 18
- Known Prisoners
- Non-English-speaking patients
- Patients in whom the device cannot be stabilized due to tissue or treatments in bilateral extremities or available extremity (burns, complex humeral fractures, dialysis fistulas etc.)
- Patients lacking capacity to consent
- Patients unable to sign written consent
- Patients without identifiable target veins by ultrasonography
- Known pregnant patients
- Previously enrolled in this study
- Previously withdrawn from this study
- Presented when no study IV proceduralists are available
- Patients in whom obtaining informed consent and being enrolled in the study would put them at risk for obtaining time sensitive medical care
Where
- Albany, New York
Related conditions & keywords
Frequently asked questions
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations