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Procedure

Midline vs Peripheral IV Catheters for Difficult Intravenous Access

N/A

Waitlist Available

Research Sponsored by Albany Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Previous requirement for a rescue device after failed IV access attempt (US guided PIV, Midline catheter, Peripherally inserted central catheter, Central venous catheter, Intraosseous catheter)

Must not have

Patients unable to sign written consent

Patients under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 months.

Awards & highlights

No Placebo-Only Group

Summary

"This trial is comparing two types of catheters, a 4-inch midline catheter and a 2-inch long IV, to see which is better for patients with difficult IV access in the emergency

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the insertion site, possible infection, bruising or bleeding, and rarely more serious complications like deep vein thrombosis. The guidewire used in midline catheters should not cause additional pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had two unsuccessful tries at getting an IV line placed by emergency staff.

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I've needed special IV access after regular attempts failed.

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I have a condition that makes IV access difficult.

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I have advanced kidney disease and use a fistula for dialysis.

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I have sickle cell disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to sign a consent form.

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I am under 18 years old.

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The device can't be placed due to issues with my limbs.

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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Catheter Dwell Time

Secondary study objectives

3- and 5-day dwell time

Complication Rates

Patient experience, satisfaction, and preference

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 9Eligibility criteria met