Superior Venous Access, Midline vs Ultrasound IVs

NCT ID: NCT03440944

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2021-01-25

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.

Conditions

Vascular Access Complication; Ultrasound Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ultrasound Guided Peripheral IV Catheter

Intervention Type: DEVICE

Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.

Midline Catheter

Patients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.

Group Type: ACTIVE_COMPARATOR

Midline Catheter

Intervention Type: DEVICE

Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.

Interventions

Ultrasound Guided Peripheral IV Catheter

Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.

Intervention Type: DEVICE

Midline Catheter

Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society for Academic Emergency Medicine

OTHER

Sponsor Role: collaborator

Bard Peripheral Vascular, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Pare, MD MHS RDMS

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

Reference Type: DERIVED

PMID: 36507736 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-37285

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-37285

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-37285

Identifier Type: -

Identifier Source: org_study_id