Superior Venous Access, Midline vs Ultrasound IVs

April 3, 2021 updated by: Boston Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device Failures Within 72 Hours
Time Frame: 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.
72 hours after device placement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IV Catheter Insertion Time
Time Frame: from catheter insertion
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
Time Frame: 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).
from catheter insertion up to 30 days
Catheter Related Costs
Time Frame: 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.
from catheter insertion up to 30 days
Patient Satisfaction
Time Frame: 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.
72 hours after catheter insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bard Peripheral Vascular, Inc.
Society for Academic Emergency Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Pare, MD MHS RDMS, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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