Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the ED
Part of paid clinical trials in Albany, New York.
- Sponsor
- Albany Medical College
- Study ID
- NCT06668766
- Status
- Recruiting
Conditions
- Difficult Intravenous Access
- Emergency Department Patient
- Midline Catheter
- Peripheral Intravenous Catheter
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 10-cm Single Lumen Mildine — DEVICEArm 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.
- 4.78 cm Long Peripheral Intravenous Catheter — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Jan 1, 2025
- Status verified
- Jan 2026
- Primary completion
- Oct 21, 2026
- Completion
- Oct 21, 2027
Study Design
- Enrollment
- 270 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: 4.78 cm Long Peripheral Intravenous CatheterThe 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.
- Experimental: 10 cm Single Lumen Midline CatheterThe 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.
Primary Outcome Measure
Completion of Care and catheter dwell time [ Time Frame: From enrollment through time to vascular access device removal, up to 28 days ]
Central Contacts
- Alexander Bracey, MD518-262-3755
- Michael J Waxman, MD518-262-3755
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Albany Medical Center Hospital | Albany | New York | 12054 | Alexander Braecy, MD (PRINCIPAL_INVESTIGATOR) |
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