Study Stopped
The study was stopped after a pause due to COVID-19 policies and new published evidence about the effectiveness of the interventon.
Superior Venous Access, Midline vs Ultrasound IVs
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedStudy Start
First participant enrolled
April 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2021
CompletedResults Posted
Study results publicly available
April 29, 2021
CompletedApril 29, 2021
April 1, 2021
2.8 years
January 11, 2018
March 10, 2021
April 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
IV Catheter Insertion Time
from catheter insertion
Total Number of Replacement Catheters
from catheter insertion up to 30 days
Catheter Related Costs
from catheter insertion up to 30 days
Patient Satisfaction
72 hours after catheter insertion
Study Arms (2)
Ultrasound Guided Peripheral IV Catheter
ACTIVE COMPARATORPatients if randomized to this group will receive a standard ultrasound guided peripheral IV. The IV is 4.88cm in length.
Midline Catheter
ACTIVE COMPARATORPatients if randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Interventions
Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Society for Academic Emergency Medicinecollaborator
- Bard Peripheral Vascular, Inc.collaborator
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
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.
PMID: 36507736DERIVED
Results Point of Contact
- Title
- Joseph Pare, MD
- Organization
- Boston University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Pare, MD MHS RDMS
Boston Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Given the devices are different we will not be able to mask.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2018
First Posted
February 22, 2018
Study Start
April 23, 2018
Primary Completion
January 25, 2021
Study Completion
January 25, 2021
Last Updated
April 29, 2021
Results First Posted
April 29, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share