Single-operator Ultrasound-guided IV Placement by Emergency Nurses

This study has been completed.
Sponsor:
Collaborator:
Baystate Medical Center
Information provided by (Responsible Party):
Scott Weiner, Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01439113
First received: September 21, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Intravenous Infusions
Procedure: Ultrasound guided IV placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Single-Operator Ultrasound-Guided vs. Standard-of-Care IV Placement by Emergency Nurses

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Need for intervention by a physician to obtain IV access [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of times a physician needs to intervene to place an IV when the nurse confronts a patient with difficult IV access


Secondary Outcome Measures:
  • Time to IV placement [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The time it takes to obtain IV access

  • Patient pain perception [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The pain (on a standard 0-10 scale) that a patient perceives when an IV is placed

  • Number of skin punctures required to obtain IV access [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of skin punctures required to obtain IV access


Enrollment: 50
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of care
In 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
Experimental: Ultrasound-guided IV
In this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439113

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Baystate Medical Center
Springfield, Massachusetts, United States
Sponsors and Collaborators
Tufts Medical Center
Baystate Medical Center
  More Information

No publications provided

Responsible Party: Scott Weiner, Director of Research, Department of Emergency Medicine, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01439113     History of Changes
Other Study ID Numbers: usivedrn
Study First Received: September 21, 2011
Last Updated: September 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Ultrasound, Difficult access

ClinicalTrials.gov processed this record on September 30, 2014