Clinical trial NCT03440944: Superior Venous Access, Midline vs Ultrasound IVs
Official title: Superior Venous Access, Midline vs Ultrasound IVs: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Access Complication
Ultrasound Therapy; Complications
Keywords: vascular access
midline cather
ultrasound guided IV
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Society for Academic Emergency Medicine
name: Bard Peripheral Vascular, Inc.
First posted: 2018-02-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized to one of two therapies, peripheral ultrasound IV or midline
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Device Failures Within 72 Hours
timeFrame: 72 hours after device placement
Secondary outcomes:
measure: IV Catheter Insertion Time
timeFrame: from catheter insertion
measure: Total Number of Replacement Catheters
timeFrame: from catheter insertion up to 30 days
measure: Catheter Related Costs
timeFrame: from catheter insertion up to 30 days
measure: Patient Satisfaction
timeFrame: 72 hours after catheter insertion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Joseph Pare, MD MHS RDMS
role: PRINCIPAL_INVESTIGATOR
References: