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Intravenous InfusionsNCT01439113

Single-operator Ultrasound-guided IV Placement by Emergency Nurses

A study testing Ultrasound guided IV placement in people with Intravenous Infusions, run by Tufts Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The placement of peripheral intravenous lines (IVs) is central to the treatment of patients in the emergency department (ED). The procedure is used for phlebotomy and administration of a variety of therapeutic medications and intravenous fluids. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Intravenous Infusions
What is being tested?
Ultrasound guided IV placement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
Jun 2010to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any patient in whom IV access is indicated but either a) have a history of difficult IV access (either by self-report or by knowledge of the nurse or physician) or in whom two unsuccessful attempts (defined as skin punctures) have failed.

Who cannot join

  • Patients will be excluded who are intoxicated, have acute psychiatric illness with exacerbation, who are prisoners, who cannot provide consent for themselves and who do not speak English.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Baystate Medical Center

    Springfield, Massachusetts

Other trials in United States

About this study

Official title: A Randomized Trial of Single-Operator Ultrasound-Guided vs. Standard-of-Care IV Placement by Emergency Nurses

The placement of peripheral intravenous lines (IVs) is central to the treatment of patients in the emergency department (ED). The procedure is used for phlebotomy and administration of a variety of therapeutic medications and intravenous fluids. This procedure is standard of care, and IVs are routinely placed by experienced emergency nurses.

Occasionally, the nurse will have difficulty placing an IV line. The most common reason for this is an underlying medical condition, such as diabetes, severe peripheral vascular disease, obesity, or a history of intravenous drug use. When a nurse is unable to place an IV, the options are:

Read more
  1. Ask another nurse to attempt the line placement
  2. Ask a physician to establish access, which usually involves placement of a central venous catheter, a time-consuming procedure with higher risk of infection than a peripheral line.

The use of bedside ultrasound has become commonplace in the modern ED, and the Tufts Medical Center ED possesses its own machine, which is used for a variety of indications including diagnosis of pregnancy, gall bladder disease, abdominal free fluid or pericardial effusion. Another key use of bedside ultrasound is the location of blood vessels. In fact, it is now expected that when placing a central venous catheter the clinician use ultrasound guidance, as the ultrasound clearly demonstrates blood vessels. The procedure is completely pain-free and harmless, and costs nothing to perform.

Recently, there has been a growing body of evidence demonstrating that placement of peripheral IVs can be facilitated by the use of ultrasound. Just as it is useful for central venous catheters, ultrasound can also clearly show smaller peripheral veins. Multiple studies have demonstrated that physicians can place IVs with ultrasound guidance.

However, nurses are the de facto experts at placing peripheral IVs as it is a usual procedure for them to perform and they perform the procedure multiple times a day. In this study, we will provide a two-hour training program to a cohort of nurses. The training program will instruct them in the use of single-operator ultrasound-guided IV placement. After training, once the nurse encounters a patient with difficult IV access (either 2 failed attempts or history of difficult access), the patient will be consented and randomized to either the standard of care (whatever the nurse elects to do) or use of the bedside ultrasound.

In the meantime, the research assistant will measure time to IV placement starting from enrollment, the number of skin punctures that are necessary to place the IV, and then ask the patient questions about satisfaction with the IV placement and the pain they experienced.

Our hypothesis is that single-operator, ED nurse use of bedside ultrasound will facilitate IV placement in patients with difficult IV access, saving time and also improving patient satisfaction and comfort.

Being tested
Ultrasound guided IV placement
Keywords
Ultrasound, Difficult access

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided IV placementProcedure or surgery

    The nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance.

Study groups in NCT01439113
Study groupRoleWhat they receive
Standard of careNo interventionIn this arm, patients who have difficult IV access will undergo the standard of care. The options include a) repeated attempts by a primary nurse, b) new attempts by a second nurse, c) central line placement by a physician, d) intraosseous line placement by a physician, e) physician use of ultrasound for peripheral IV placement
Ultrasound-guided IVExperimentalIn this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins
Receives: Procedure: Ultrasound guided IV placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Need for intervention by a physician to obtain IV access

    The number of times a physician needs to intervene to place an IV when the nurse confronts a patient with difficult IV access

    Measured: 1 year

Secondary outcomes (3)
  1. Time to IV placement

    The time it takes to obtain IV access

    Measured: 1 year

  2. Patient pain perception

    The pain (on a standard 0-10 scale) that a patient perceives when an IV is placed

    Measured: 1 year

  3. Number of skin punctures required to obtain IV access

    The number of skin punctures required to obtain IV access

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01439113
Sponsor's protocol ID
usivedrn
Status last verified
Mar 2023
First submitted
21 Sep 2011
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided IV placement in people with Intravenous Infusions, run by Tufts Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for intervention by a physician to obtain IV access (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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