Superior Venous Access, Midline vs Ultrasound IVs

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

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.

Study Overview

• Status: Terminated
• Conditions: Ultrasound Therapy; Complications; Vascular Access Complication
• Intervention / Treatment: Device: Ultrasound Guided Peripheral IV Catheter; Device: Midline Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Bard Peripheral Vascular, Inc.; Society for Academic Emergency Medicine
• Investigators: Principal Investigator: Joseph Pare, MD MHS RDMS, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: vascular access; ultrasound guided IV; midline cather
• Other Study ID Numbers: H-37285 (Other Grant/Funding Number: Bard Peripheral Vascular, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes