Superior Venous Access, Midline vs Ultrasound IVs

Not Applicable

Terminated

Conditions: Ultrasound Therapy; Complications
Vascular Access Complication

Interventions: Device: Ultrasound Guided Peripheral IV Catheter
Device: Midline Catheter

Registration Number: NCT03440944

Lead Sponsor: Boston Medical Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 18

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound Guided Peripheral IV Catheter	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.
Midline Catheter	Midline Catheter	Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.

Primary Outcome Measures

Name	Time	Method
Device Failures Within 72 Hours	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 Outcome Measures

Name	Time	Method
Total Number of Replacement Catheters	from catheter insertion up to 30 days	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).
Catheter Related Costs	from catheter insertion up to 30 days	The mean costs per patient associated with the placement and replacement of catheters for each participant will be calculated.
IV Catheter Insertion Time	from catheter insertion	The time it takes to insert the IV catheter will be documented in minutes for each study participant.
Patient Satisfaction	72 hours after catheter insertion	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.