270 Participants Needed

Midline vs Peripheral IV Catheters for Difficult Intravenous Access

AB
MJ
Overseen ByMichael J Waxman, 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)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing different types of IV catheters, so it's unlikely that your medications would be affected, but you should confirm with the study team.

What data supports the effectiveness of the treatment Long Peripheral Intravenous Catheter, Single Lumen Midline Catheter for difficult intravenous access?

Research shows that midline catheters, which are inserted in the upper arm, are effective for patients with difficult vein access and result in fewer complications compared to other types of catheters. They are a good alternative for patients needing IV therapy for more than 5 days.12345

Is it safe to use midline catheters for intravenous access?

Research shows that midline catheters are generally safe for providing intravenous access, with fewer complications compared to other types of catheters. Studies report low rates of complications like phlebitis (vein inflammation) and deep vein thrombosis (blood clots), and no infections were documented.12467

How is the treatment with midline and long peripheral intravenous catheters different from other treatments for difficult intravenous access?

Midline catheters are unique because they are inserted in the upper arm and are ideal for patients with difficult vein access, offering longer use with fewer complications compared to standard peripheral intravenous catheters. They provide a middle ground between short peripheral catheters and more invasive central catheters, making them a safer and more effective option for prolonged intravenous access.12578

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients in the emergency department who have veins that are hard to access for IV insertion. It's not specified who can't join, but typically those with certain health conditions or previous complications related to IV access might be excluded.

Inclusion Criteria

Self-reported history of difficult IV access and history of requiring 2 or more IV attempts on a previous visit
Prior or current implanted port device
History of or active intravenous drug use
See 6 more

Exclusion Criteria

Known Prisoners
Non-English-speaking patients
Patients without identifiable target veins by ultrasonography
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a long peripheral intravenous catheter or a single lumen midline catheter, with procedures performed in the emergency department.

Up to 28 days
1 visit (in-person)

Follow-up

Participants are monitored for catheter survival, complications, and patient satisfaction.

1 month

Treatment Details

Interventions

  • Long Peripheral Intravenous Catheter
  • Single Lumen Midline Catheter
Trial Overview The study compares two types of catheters: a 10-cm single lumen midline and a standard 4.78 cm long peripheral intravenous catheter, to see which is better for administering medication in patients with difficult IV access.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 10 cm Single Lumen Midline CatheterExperimental Treatment1 Intervention
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.
Group II: 4.78 cm Long Peripheral Intravenous CatheterActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials
96
Recruited
12,700+

References

Safety and efficacy of midline catheters versus peripheral intravenous catheters: A pilot randomized controlled trial. [2023]
Use of and patient-reported complications related to midline catheters and peripherally inserted central catheters. [2021]
The efficacy of midline catheters-a prospective, randomized, active-controlled study. [2021]
PICC vs. midline catheter use for short-term indications was linked to major complications at ≤30 d. [2022]
Long peripheral catheters and midline catheters: Insights from a survey of vascular access specialists. [2022]
Implementation of a midline catheter service in a regional setting. [2023]
Midline catheters: A 3-year experience at a veterans administration medical center. [2023]
Use of midline catheters in low birth weight infants. [2004]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security