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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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
- 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.
- Conditions
- Intravenous Infusions
- 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 group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 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 |
| Ultrasound-guided IV | Experimental | In 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.
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)
Time to IV placement
The time it takes to obtain IV access
Measured: 1 year
Patient pain perception
The pain (on a standard 0-10 scale) that a patient perceives when an IV is placed
Measured: 1 year
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.
- First posted22 Sep 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous InfusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baystate Medical Center
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Single-Operator Ultrasound-Guided vs. Standard-of-Care IV Placement by Emergency Nurses
- ClinicalTrials.gov ID
- NCT01439113
- Acronym / sponsor ID
- usivedrn
- Conditions
- Intravenous Infusions
- Keywords
- Ultrasound, Difficult access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Baystate Medical Center
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –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 |
| Ultrasound-guided IV | Experimental | Procedure: Ultrasound guided IV placementIn this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided IV placementThe nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance. | Procedure or surgery | Ultrasound-guided IV |
Primary outcome
Need for intervention by a physician to obtain IV access
Time frame: 1 year
The number of times a physician needs to intervene to place an IV when the nurse confronts a patient with difficult IV access
3 secondary outcomes
Time to IV placement
Time frame: 1 year
Patient pain perception
Time frame: 1 year
Number of skin punctures required to obtain IV access
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.