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Clinical Trials/NCT03440944
NCT03440944
Terminated
Not Applicable

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

Boston Medical Center1 site in 1 country18 target enrollmentApril 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Access Complication
Sponsor
Boston Medical Center
Enrollment
18
Locations
1
Primary Endpoint
Device Failures Within 72 Hours
Status
Terminated
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 23, 2018
End Date
January 25, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.
  • 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

Outcomes

Primary Outcomes

Device Failures Within 72 Hours

Time Frame: 72 hours after device placement

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.

Secondary Outcomes

  • Total Number of Replacement Catheters(from catheter insertion up to 30 days)
  • Catheter Related Costs(from catheter insertion up to 30 days)
  • IV Catheter Insertion Time(from catheter insertion)
  • Patient Satisfaction(72 hours after catheter insertion)

Study Sites (1)

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