Superior Venous Access, Midline vs Ultrasound IVs

Study Overview
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Brief Summary
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Obtaining intravenous access (IVA) is the most common procedure performed in the emergency department (ED). Placement of IVA allows for blood work and delivery of intravenous fluids and medications. The implementation of ultrasound guided peripheral IVs (UGPIV) have allowed for ultrasound to be used to place an IV into patients with difficult vein access (DVA). An alternative device to place is a midline catheter (MC). The use of MCs against UGPIV has not been compared in a randomized study. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. Aim 2: To collect information to perform a direct cost analysis of UGPIV against that of the midline catheter. Aim 3: Assess patient satisfaction.

Detailed Description
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This is a randomized controlled trial to determine if the midline catheter is superior to the ultrasound guided IV with respect to survival at 72 hours. Aim 1: To determine if UGPIVs have a higher failure rate than midline catheters within 72 hours of placement. There are several reasons why UGPIVs may fail. UGPIVs are shorter than midline catheters, and shorter catheters may fail due to infiltration which can be a result of malposition as well as having the catheter pull out of the vessel. It is being hypothesized that by using a midline catheter with a guidewire for placement with additional catheter length placed into the vessel, midlines will be superior to UGP\Vs with regards to survival time of the catheter. The investigators will assess catheter survival daily until 72 hours (when UGPIV are recommended to be changed). The total lifetime of the midline catheters will be recorded. Aim 2: To perform a direct cost analysis of UGPIV against that of the midline catheter. This study will not be large enough to complete a robust cost effectiveness analysis to compare UGPIV to mid line catheters. As a part of this study the investigators will collect information including but not limited to: the number of catheters used for IVA attempts, time for placement of each device complications, and need for additional IVA during hospitalization. Aim 3: For patients that remain hospitalized at 72 hours a satisfaction survey will be administered to determine patient experience and preference for the type of vascular access that they receive.

Official Title
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Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial

Conditions
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Vascular Access Complication, Ultrasound Therapy; Complications

Intervention / Treatment
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* Device: Ultrasound Guided Peripheral IV Catheter
* Device: Midline Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at least 18 years of age being treated in the emergency department at Boston Medical Center Standard IVA cannot be obtained by two qualified ER staff Have an upper extremity (left or right arm) that can accept a deep venous IV Clinical team believes the patient is likely to require inpatient admission at time of needing IV access English speaking Able to provide consent Exclusion Criteria: Patient expected to be discharged from the emergency department or discharged from the hospital within 1 nights stay. Prisoner Pregnancy Requires central line or midline catheter as an expected requirement of care Patients who are expected to require medication that is not approved for administration via a peripherally guided IV or midline as defined by hospital pharmacy guidelines. Patients known to have bacteremia or have a high suspicion of bacteremia The patient is known or is suspected to be allergic to materials contained in the device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized to one of two therapies, peripheral ultrasound IV or midline
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound Guided Peripheral IV Catheter<br>Patients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length. | Device: Ultrasound Guided Peripheral IV Catheter<br>* Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.<br>|
| Active Comparator: Midline Catheter<br>Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length. | Device: Midline Catheter<br>* Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Failures Within 72 Hours | Total number and percentage of device failures within 72 hours of placement based on midline and ultrasound guided peripheral IV catheter. Medical record review and in person visits with medical treatment teams and patients were used to assess if device failure occurred within 72 hours. Device failure was determined by needing to have any device replaced or removed for clinical care. | 72 hours after device placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV Catheter Insertion Time | The time it takes to insert the IV catheter will be documented in minutes for each study participant. | from catheter insertion | 
| Total Number of Replacement Catheters | The total number of replacement IV catheters will be documented. This will be assessed based on each group (Ultrasound Guided Peripheral IV Catheter and Midline Catheter). | from catheter insertion up to 30 days | 
| Catheter Related Costs | The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated. | from catheter insertion up to 30 days | 
| Patient Satisfaction | Participant experience and satisfaction will be assessed with a short survey that will be given to participants who stay at least 72 hours after catheter insertion. | 72 hours after catheter insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular access, midline cather, ultrasound guided IV