Single-operator Ultrasound-guided IV Placement by Emergency Nurses
A Randomized Trial of Single-Operator Ultrasound-Guided vs. Standard-of-Care IV Placement by Emergency Nurses
1 other identifier
interventional
50
1 country
2
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedMarch 28, 2023
March 1, 2023
1 year
September 21, 2011
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
1 year
Secondary Outcomes (3)
Time to IV placement
1 year
Patient pain perception
1 year
Number of skin punctures required to obtain IV access
1 year
Study Arms (2)
Standard of care
NO 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 IV
EXPERIMENTALIn this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins
Interventions
The nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Medical Centerlead
- Baystate Medical Centercollaborator
Study Sites (2)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2011
First Posted
September 22, 2011
Study Start
June 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 28, 2023
Record last verified: 2023-03