Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the ED

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbany Medical College

About 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 does not accept healthy volunteers

Qualifiers

Two failed attempts at landmark based IV or US-guided peripheral vascular access by qualified ED staff

History of requiring 2 or more IV attempts on a previous visit (either self-reported or documented in the electronic medical record)

US guided PIV

Midline catheter

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 10-cm Single Lumen Mildine

    Device

    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.

  • 4.78 cm Long Peripheral Intravenous Catheter

    Device

    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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: 4.78 cm Long Peripheral Intravenous CatheterActive comparator 1 intervention
Group B: 10 cm Single Lumen Midline CatheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Completion of Care and catheter dwell time

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.

Time frame
From enrollment through time to vascular access device removal, up to 28 days

Secondary outcomes

1

Complication Rates

We will measure and compare the proportion of complications in each study arm. We will record the qualitative type of complication (if any) experienced in each study arm for potential comparison of complication rates by complication type.

Time frame
through study completion, an average of 2 months.
2

Patient experience, satisfaction, and preference

We will compare subject questionnaire responses, provider (proceduralists) questionnaire responses, and operational characteristics based on descriptive statistics, chi-square tests, or t tests as appropriate. This will be performed on a 10-point Likert scale, where higher scores are better outcomes.

Time frame
At the time of patient enrollment
3

Procedural Time

We will measure how long it takes to complete each procedure, including set up time.

Time frame
At the time of patient enrollment
4

3- and 5-day dwell time

We will also report the proportion of each type of catheter that is in place and functional at 3 days and 5 days post placement and the median dwell times.

Time frame
From enrollment through time to vascular access device removal, up to 28 days

Other outcomes

Sponsors and contacts

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