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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439113
Other study ID # usivedrn
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2010
Est. completion date June 2011

Study information

Verified date March 2023
Source Tufts Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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: 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound guided IV placement
The nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance.

Locations

Country Name City State
United States Tufts Medical Center Boston Massachusetts
United States Baystate Medical Center Springfield Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Tufts Medical Center Baystate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
Secondary Time to IV placement The time it takes to obtain IV access 1 year
Secondary Patient pain perception The pain (on a standard 0-10 scale) that a patient perceives when an IV is placed 1 year
Secondary Number of skin punctures required to obtain IV access The number of skin punctures required to obtain IV access 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05522127 - Restritive and Liberal Fluid Management and Colonoscopy N/A