Single-operator Ultrasound-guided IV Placement by Emergency Nurses
Primary Purpose
Intravenous Infusions
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound guided IV placement
Sponsored by

About this trial
This is an interventional treatment trial for Intravenous Infusions focused on measuring Ultrasound, Difficult access
Eligibility 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.
Sites / Locations
- Tufts Medical Center
- Baystate Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care
Ultrasound-guided IV
Arm Description
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
In this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to IV placement
The time it takes to obtain IV access
Patient pain perception
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
The number of skin punctures required to obtain IV access
Full Information
NCT ID
NCT01439113
First Posted
September 21, 2011
Last Updated
March 27, 2023
Sponsor
Tufts Medical Center
Collaborators
Baystate Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01439113
Brief Title
Single-operator Ultrasound-guided IV Placement by Emergency Nurses
Official Title
A Randomized Trial of Single-Operator Ultrasound-Guided vs. Standard-of-Care IV Placement by Emergency Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Baystate Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
Ask another nurse to attempt the line placement
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravenous Infusions
Keywords
Ultrasound, Difficult access
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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
Arm Title
Ultrasound-guided IV
Arm Type
Experimental
Arm Description
In this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided IV placement
Intervention Description
The nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance.
Primary Outcome Measure Information:
Title
Need for intervention by a physician to obtain IV access
Description
The number of times a physician needs to intervene to place an IV when the nurse confronts a patient with difficult IV access
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to IV placement
Description
The time it takes to obtain IV access
Time Frame
1 year
Title
Patient pain perception
Description
The pain (on a standard 0-10 scale) that a patient perceives when an IV is placed
Time Frame
1 year
Title
Number of skin punctures required to obtain IV access
Description
The number of skin punctures required to obtain IV access
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single-operator Ultrasound-guided IV Placement by Emergency Nurses
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