NCT03440944

Superior Venous Access, Midline vs Ultrasound IVs

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Access Complication
• Ultrasound Therapy; Complications

Interventions

Type	Name	Description
DEVICE	Ultrasound Guided Peripheral IV Catheter	Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
DEVICE	Midline Catheter	Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.

Timeline

• Start date: 2018-04-23
• Primary completion: 2021-01-25
• Completion: 2021-01-25
• First posted: 2018-02-22
• Last updated: 2021-04-29
• Results posted: 2021-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study