Patients With Peripheral Intravenous Access LinesNCT01859559
Evaluate Initial Success Rate of Ultrasound Guided Versus Landmark Approach For Peripheral Intravenous Access
A study testing Ultrasound-guided peripheral intravenous access line placement and Landmark Approach to peripheral intravenous access line placement in people with Patients With Peripheral Intravenous Access Lines, run by George Washington University at 1 site in United States.
Trial summary
The primary objective of this randomized controlled trial (RCT) is to compare the success rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional, landmark approach among patients with varying degrees of intravenous access difficulty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Peripheral Intravenous Access Lines
- What is being tested?
- Ultrasound-guided peripheral intravenous access line placement and Landmark Approach to peripheral intravenous access line placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,189 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- peripheral venous (PIV) access line ordered by a physician during their emergency department visit.
Who cannot join
- Non-English or non-spanish speaking
- already enrolled in a different study during the ED visit
- too sick, patient requires intravenous access quickly and can not take the time to enroll in study
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized Controlled Trial To Compare The Initial Success Rate of Ultrasound Guided Versus Landmark Approach For Placement of Peripheral Intravenous Access Lines in Emergency Department Patients
The primary objective of this randomized controlled trial (RCT) is to compare the success rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional, landmark approach among patients with varying degrees of intravenous access difficulty. In addition to comparing overall initial success rates of the two methods, we will also compare the success rates by degree of intravenous access difficulty (3 main subject subgroups) and by operator experience (approximately 20 emergency department technicians).
The main hypothesis is that the initial success rate will be significantly higher (5% or greater) for ultrasound guided peripheral intravenous access compared to landmark approach among patients who are judged to have difficult intravenous access but no significant difference (i.e. < 5%) among patients judged to have easy intravenous access.
Read the detailed description
This is a randomized controlled trial with a two group parallel design that will compare the initial success rate of peripheral intravenous line (PIV) placement between the traditional, landmark approach versus ultrasound guided. Emergency department (ED) patients who are in a treatment room and require a PIV line are eligible for the study. For those who are eligible, the ED technician and an ED nurse will each complete a clinical data sheet that documents the degree of IV access difficulty.
For those who enroll, the research assistant (RA) will randomize the subject to one of two treatment groups: (1) ultrasound guided or; (2) landmark approach. The ED technician will perform the PIV placement based on the treatment group assigned through the randomization process. The RA will be present during the PIV placement and will ask the patient prior to the procedure about factors that may influence IV access (i.e. self-reported weight and height, presence of chronic conditions). The RA will also document the ED outcomes of the procedure (i.e. duration of procedure, success or failure, complications of procedure) and query the patient on the extent of discomfort associated with the procedure. Finally, for those subjects who are admitted to the hospital, a RA will conduct follow-up on the PIV line to determine how long it is used on the ward and the reason for taking it out (i.e. no longer needed, infection, infiltration, fell out, etc). It is hospital policy that PIV lines be changed every 72 hours to prevent infection so we anticipate that the maximum follow-up of each ED PIV line placed will be 72 hours.
There are two treatment groups, the ultrasound guided treatment group and the traditional, landmark group. For both treatment groups, a tourniquet will be placed above the upper extremity vein chosen for cannulation. For the landmark approach, the ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the IV line. If the patient is randomized to the ultrasound group, the operator will use ultrasound to help visualize the vein and direct line placement. When using ultrasound, the ED technicians will employ a one-person technique. For both treatment groups, if the first attempt fails, we will randomize the subject again to one of the two treatment arms. We are randomizing a second time because failure at first attempt is a good marker of the difficulty of the procedure. By randomizing a second time, we will be able to determine whether either method is superior after one failed attempt. After the second failed attempt, the ED technician can use whatever method he/she chooses to place the line.
Because of the nature of the intervention, this RCT is unblinded.
- Being tested
- Ultrasound-guided peripheral intravenous access line placement, Landmark Approach to peripheral intravenous access line placement
- Keywords
- ultrasound, peripheral intravenous access, operator experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided peripheral intravenous access line placementProcedure or surgery
The ED technician will use an ultrasound machine with a vascular probe to visualize the vein and guide the PIV line using a one-operator dynamic technique.
Landmark Approach to peripheral intravenous access line placementProcedure or surgery
ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the peripheral intravenous access line in the upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Easy Access | Experimental | This arm will included emergency department patients that are judged to have easy intravenous access in at least one of the upper extremities by the ED technician. Receives: Procedure: Ultrasound-guided peripheral intravenous access line placement; Procedure: Landmark Approach to peripheral intravenous access line placement |
| Difficult Access By Clinician Judgment | Experimental | This arm will include patients that at least one vein is visible or palpable in one of the upper extremities but either the ED technician and/or ED nurse judges the patient to have difficult intravenous access. Receives: Procedure: Ultrasound-guided peripheral intravenous access line placement; Procedure: Landmark Approach to peripheral intravenous access line placement |
| Non visible and Non palpable | Experimental | This arm will include patients for whom neither the ED technician nor an ED nurse can identify a visible or palpable vein that is suitable for an intravenous access line in either upper extremity. Receives: Procedure: Ultrasound-guided peripheral intravenous access line placement; Procedure: Landmark Approach to peripheral intravenous access line placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial success rate
A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture.
Measured: immediatetely after first attempt, average attempt takes 15 minutes
Secondary outcomes (1)
Any complications associated with the PIV line
Incidence of infiltration, arterial puncture, or nerve puncture
Measured: within ED visit, average ED length of stay is 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Peripheral Intravenous Access LinesStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- 1,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Melissa McCarthy, George Washington University
- Investigators
- Melissa L McCarthy, ScD, Principal investigator, George Washington UniversityHamid Shokoohi, MD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859559
- Sponsor's protocol ID
- PIV-RCT-ED
- Status last verified
- Dec 2018
- First submitted
- 16 May 2013
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically guided peripheral intravenous cannulation of children and adults: a systematic review and meta-analysis. Ann Emerg Med. 2013 Apr;61(4):444-454.e1. doi: 10.1016/j.annemergmed.2012.11.014. Epub 2013 Feb 15.
PubMed 23415740McCarthy ML, Shokoohi H, Boniface KS, Eggelton R, Lowey A, Lim K, Shesser R, Li X, Zeger SL. Ultrasonography Versus Landmark for Peripheral Intravenous Cannulation: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):10-8. doi: 10.1016/j.annemergmed.2015.09.009. Epub 2015 Oct 23.
PubMed 26475248Shokoohi H, Boniface KS, Kulie P, Long A, McCarthy M. The Utility and Survivorship of Peripheral Intravenous Catheters Inserted in the Emergency Department. Ann Emerg Med. 2019 Sep;74(3):381-390. doi: 10.1016/j.annemergmed.2019.02.003. Epub 2019 Mar 27.
PubMed 30926188
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Compare The Initial Success Rate of Ultrasound Guided Versus Landmark Approach For Placement of Peripheral Intravenous Access Lines in Emergency Department Patients
- ClinicalTrials.gov ID
- NCT01859559
- Acronym / sponsor ID
- PIV-RCT-ED
- Keywords
- ultrasound, peripheral intravenous access, operator experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 May 2013 (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 primary objective of this randomized controlled trial (RCT) is to compare the success rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional, landmark approach among patients with varying degrees of intravenous access difficulty. In addition to comparing overall initial success rates of the two methods, we will also compare the success rates by degree of intravenous access difficulty (3 main subject subgroups) and by operator experience (approximately 20 emergency department technicians).
The main hypothesis is that the initial success rate will be significantly higher (5% or greater) for ultrasound guided peripheral intravenous access compared to landmark approach among patients who are judged to have difficult intravenous access but no significant difference (i.e. < 5%) among patients judged to have easy intravenous access.
Detailed description
This is a randomized controlled trial with a two group parallel design that will compare the initial success rate of peripheral intravenous line (PIV) placement between the traditional, landmark approach versus ultrasound guided. Emergency department (ED) patients who are in a treatment room and require a PIV line are eligible for the study. For those who are eligible, the ED technician and an ED nurse will each complete a clinical data sheet that documents the degree of IV access difficulty.
For those who enroll, the research assistant (RA) will randomize the subject to one of two treatment groups: (1) ultrasound guided or; (2) landmark approach. The ED technician will perform the PIV placement based on the treatment group assigned through the randomization process. The RA will be present during the PIV placement and will ask the patient prior to the procedure about factors that may influence IV access (i.e. self-reported weight and height, presence of chronic conditions). The RA will also document the ED outcomes of the procedure (i.e. duration of procedure, success or failure, complications of procedure) and query the patient on the extent of discomfort associated with the procedure. Finally, for those subjects who are admitted to the hospital, a RA will conduct follow-up on the PIV line to determine how long it is used on the ward and the reason for taking it out (i.e. no longer needed, infection, infiltration, fell out, etc). It is hospital policy that PIV lines be changed every 72 hours to prevent infection so we anticipate that the maximum follow-up of each ED PIV line placed will be 72 hours.
There are two treatment groups, the ultrasound guided treatment group and the traditional, landmark group. For both treatment groups, a tourniquet will be placed above the upper extremity vein chosen for cannulation. For the landmark approach, the ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the IV line. If the patient is randomized to the ultrasound group, the operator will use ultrasound to help visualize the vein and direct line placement. When using ultrasound, the ED technicians will employ a one-person technique. For both treatment groups, if the first attempt fails, we will randomize the subject again to one of the two treatment arms. We are randomizing a second time because failure at first attempt is a good marker of the difficulty of the procedure. By randomizing a second time, we will be able to determine whether either method is superior after one failed attempt. After the second failed attempt, the ED technician can use whatever method he/she chooses to place the line.
Because of the nature of the intervention, this RCT is unblinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Easy Access | Experimental | Procedure: Ultrasound-guided peripheral intravenous access line placement, Procedure: Landmark Approach to peripheral intravenous access line placementThis arm will included emergency department patients that are judged to have easy intravenous access in at least one of the upper extremities by the ED technician. |
| Difficult Access By Clinician Judgment | Experimental | Procedure: Ultrasound-guided peripheral intravenous access line placement, Procedure: Landmark Approach to peripheral intravenous access line placementThis arm will include patients that at least one vein is visible or palpable in one of the upper extremities but either the ED technician and/or ED nurse judges the patient to have difficult intravenous access. |
| Non visible and Non palpable | Experimental | Procedure: Ultrasound-guided peripheral intravenous access line placement, Procedure: Landmark Approach to peripheral intravenous access line placementThis arm will include patients for whom neither the ED technician nor an ED nurse can identify a visible or palpable vein that is suitable for an intravenous access line in either upper extremity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- peripheral venous (PIV) access line ordered by a physician during their emergency department visit.
Key exclusion criteria (3 listed)
- Non-English or non-spanish speaking
- already enrolled in a different study during the ED visit
- too sick, patient requires intravenous access quickly and can not take the time to enroll in study
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 peripheral intravenous access line placementThe ED technician will use an ultrasound machine with a vascular probe to visualize the vein and guide the PIV line using a one-operator dynamic technique. | Procedure or surgery | Difficult Access By Clinician Judgment, Easy Access, Non visible and Non palpable |
| Landmark Approach to peripheral intravenous access line placementED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the peripheral intravenous access line in the upper extremity. | Procedure or surgery | Difficult Access By Clinician Judgment, Easy Access, Non visible and Non palpable |
Primary outcome
Initial success rate
Time frame: immediatetely after first attempt, average attempt takes 15 minutes
A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture.
1 secondary outcome
Any complications associated with the PIV line
Time frame: within ED visit, average ED length of stay is 6 hours
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 7 Dec 2018.
- Background: PubMed 23415740Heinrichs J, Fritze Z, Vandermeer B, Klassen T, Curtis S. Ultrasonographically guided peripheral intravenous cannulation of children and adults: a systematic review and meta-analysis. Ann Emerg Med. 2013 Apr;61(4):444-454.e1. doi: 10.1016/j.annemergmed.2012.11.014. Epub 2013 Feb 15.
- Background: PubMed 26475248McCarthy ML, Shokoohi H, Boniface KS, Eggelton R, Lowey A, Lim K, Shesser R, Li X, Zeger SL. Ultrasonography Versus Landmark for Peripheral Intravenous Cannulation: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):10-8. doi: 10.1016/j.annemergmed.2015.09.009. Epub 2015 Oct 23.
- Derived from this study: PubMed 30926188Shokoohi H, Boniface KS, Kulie P, Long A, McCarthy M. The Utility and Survivorship of Peripheral Intravenous Catheters Inserted in the Emergency Department. Ann Emerg Med. 2019 Sep;74(3):381-390. doi: 10.1016/j.annemergmed.2019.02.003. Epub 2019 Mar 27.
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.
Melissa L McCarthy, ScD principal investigator
George Washington University
Hamid Shokoohi, MD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided peripheral intravenous access line placement and Landmark Approach to peripheral intravenous access line placement in people with Patients With Peripheral Intravenous Access Lines, run by George Washington University at 1 site 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 2 inclusion and 3 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Initial success rate (time frame: immediatetely after first attempt, average attempt takes 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859559, which also lists 3 linked publications.
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 7 Dec 2018.