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

NCT06668766 | Recruiting DMC FDA Device

• 1 other identifier: 6890
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Intravenous Catheter; Emergency Department Patient; Difficult Intravenous Access; Midline Catheter

Keywords

midline catheter; difficult intravenous access; difficult IV access; USGIV; long peripheral IV; peripheral IV; peripheral intravenous catheter; Emergency department; emergency medicine; single lumen midline catheter; long peripheral intravenous catheter

Outcome Measures

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.

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

Secondary Outcomes (5)

• Complication Rates

  through study completion, an average of 2 months.

• Patient experience, satisfaction, and preference

  At the time of patient enrollment

• Procedural Time

  At the time of patient enrollment

• 3- and 5-day dwell time

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

• Procdural Time

  At enrollment through device insertion, up to 2 hours

Study Arms (2)

4.78 cm Long Peripheral Intravenous Catheter

ACTIVE COMPARATOR

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.

Device: 4.78 cm Long Peripheral Intravenous Catheter

10 cm Single Lumen Midline Catheter

EXPERIMENTAL

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: 10-cm Single Lumen Mildine

Interventions

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.

4.78 cm Long Peripheral Intravenous Catheter

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.

10 cm Single Lumen Midline Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center Hospital

Albany, New York, 12054, United States

RECRUITING

Related Publications (8)

• Prasanna N, Yamane D, Haridasa N, Davison D, Sparks A, Hawkins K. Safety and efficacy of vasopressor administration through midline catheters. J Crit Care. 2021 Feb;61:1-4. doi: 10.1016/j.jcrc.2020.09.024. Epub 2020 Oct 2.

  PMID: 33049486 RESULT

• Tripathi S, Kumar S, Kaushik S. The Practice and Complications of Midline Catheters: A Systematic Review. Crit Care Med. 2021 Feb 1;49(2):e140-e150. doi: 10.1097/CCM.0000000000004764.

  PMID: 33372744 RESULT

• Bahl A, Hang B, Brackney A, Joseph S, Karabon P, Mohammad A, Nnanabu I, Shotkin P. Standard long IV catheters versus extended dwell catheters: A randomized comparison of ultrasound-guided catheter survival. Am J Emerg Med. 2019 Apr;37(4):715-721. doi: 10.1016/j.ajem.2018.07.031. Epub 2018 Jul 19.

  PMID: 30037560 RESULT

• Greenwald RA, Rheingold OJ, Chiprut RO, Rogers AI. Local gangrene: a complication of peripheral Pitressin therapy for bleeding esophageal varices. Gastroenterology. 1978 Apr;74(4):744-6.

  PMID: 305380 RESULT

• Anderson JR, Johnston GW. Development of cutaneous gangrene during continuous peripheral infusion of vasopressin. Br Med J (Clin Res Ed). 1983 Dec 3;287(6406):1657-8. doi: 10.1136/bmj.287.6406.1657.

  PMID: 6416538 RESULT

• Elia F, Ferrari G, Molino P, Converso M, De Filippi G, Milan A, Apra F. Standard-length catheters vs long catheters in ultrasound-guided peripheral vein cannulation. Am J Emerg Med. 2012 Jun;30(5):712-6. doi: 10.1016/j.ajem.2011.04.019. Epub 2011 Jun 23.

  PMID: 21703801 RESULT

• Bahl A, Hijazi M, Chen NW, Lachapelle-Clavette L, Price J. Ultralong Versus Standard Long Peripheral Intravenous Catheters: A Randomized Controlled Trial of Ultrasonographically Guided Catheter Survival. Ann Emerg Med. 2020 Aug;76(2):134-142. doi: 10.1016/j.annemergmed.2019.11.013. Epub 2020 Jan 16.

  PMID: 31955940 RESULT

• Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.

  PMID: 10577399 RESULT

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexander Bracey, MD

CONTACT

518-262-3755; braceya@amc.edu

Michael J Waxman, MD

CONTACT

518-262-3755; waxmanm@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Director

Model Details: This is a single center, prospective, 2-arm, nonblinded, randomized clinical trial to determine if midline catheters (10 cm) are superior to the long peripheral intravenous catheterss (4.78-cm) may with respect to dwell time, dislodgement and infiltration rates, and patient preference.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 31, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)