IV AccessNCT03231345
Ultrasound-guided Peripheral IJ Study
A study testing US guided IJ and Ultrasound in people with IV Access, run by University Medical Center of Southern Nevada at 1 site in United States.
Trial summary
Difficult venous access in some patients such as those with obesity, IV drug use, chronic illness, or vascular pathology often causes increased discomfort and delayed patient care due to multiple attempts to gain venous access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Access
- What is being tested?
- US guided IJ and Ultrasound
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2016to May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 2 unsuccessful attempts at peripheral IV access by ED nursing
- Age 18 or older
Who cannot join
- Critically ill patients with clinical indications for emergent central venous access.
- Overlying skin infection
- External jugular vein easily visible for cannulation
- Patient in law enforcement custody
- Patient who is known to be pregnant or self identifies as pregnant
- Patient lacking decision making capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center of Southen Nevada
Las Vegas, Nevada, 89102
About this study
Official title: Ultrasound-guided Placement of Peripheral Intravenous Lines in the Internal Jugular Vein.
Difficult venous access in some patients such as those with obesity, IV drug use, chronic illness, or vascular pathology often causes increased discomfort and delayed patient care due to multiple attempts to gain venous access. If access is achieved at all, it usually results in a much smaller catheter than needed to provide optimal care for the patient. Ultrasound-guided placement of a peripheral IV in the internal jugular vein is common in the investigators' emergency department and is gaining popularity across the US. This study investigates the utility and safety of placing an ultrasound-guided peripheral IV catheter in the internal jugular vein.
Read the detailed description
Intravenous access in the emergency department (ED) patient is essential for medication delivery, IV fluid resuscitation, rapid serum laboratory diagnostics, and administration of IV contrast for CT scans. Some patients, such as those with obesity, IV drug abuse, chronic illnesses, or vascular pathology may have difficult IV access. These patients are problematic for the busy ED nurse and physician as this can lead to a time consuming process, which slows efficiency and patient care.
Previously, patients with difficult IV access often required central venous catheterization, a procedure that can result in a number of serious complications (1). More recently, ultrasound guidance has been touted as an effective means to achieve peripheral IV access on these patients (2). In one study (2), there was a 73% first attempt cannulation rate, which seems respectable, but not excellent. Additionally, 8% of the successful IVs failed within one hour (2). Another study compared ultrasonographically guided peripheral IVs to non-ultrasonographically guided IVs, and it found that using ultrasound did not decrease the amount of time or the number of attempts it took to successfully place a peripheral IV (3). Although ultrasound-guided peripheral IV's have a role, there remains room for improvement in being able to achieve rapid IV access in those patients who need IV access on an urgent basis.
It seems that we still have room to improve our ability to obtain difficult IV access, and a relatively new technique may be the answer. Ultrasound guided IVs are typically attempted in the upper extremities, targeting the brachial or basilic veins, but a recently described technique --- the "peripheral IJ" --- involves placement of a peripheral IV catheter in the internal jugular vein (4,5).
The peripheral IJ is gaining popularity in the investigators' ED as a solution to the difficult vascular access patient. In the investigators' clinical experience, it is a quick and easy procedure that is also safe, tolerated well by patients, and requires few resources. Several small studies have concluded that this is a fast and safe procedure and a feasible alternative to central access in the difficult vascular access patient (4-7). These studies mention the theoretical risks as being similar to central venous access such as carotid artery puncture, hematoma, pneumothorax, and line infection, however none of these have actually been reported (4-7). Therefore, we seek primarily to determine the average number of attempts to cannulation for ultrasound-guided peripheral IJ placement. Secondarily, we wish to determine: 1) the prevalence of potential complications related to this procedure 2) the average time it takes the emergency physician to complete the procedure 3) the patient's satisfaction with the procedure. We will compare the data from this study to the published data for other types of ultrasound-guided peripheral IVs.
- Conditions
- IV Access
- Being tested
- US guided IJ, Ultrasound
- Keywords
- Peripheral IV, Internal jugular vein, IJ, Peripheral IJ, Ultrasound-guided IJ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided IJProcedure or surgery
Also called Ultrasound-guided Internal Jugular vein
IV catheter placement
UltrasoundDevice
Ultrasound-guided Internal Jugular vein
| Study group | Role | What they receive |
|---|---|---|
| US guided IJ | Experimental | A physician placed ultrasound-guided IV in the internal jugular vein Receives: Procedure: US guided IJ; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Cannulation of the Internal Jugular Vein
The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.
Measured: Less than 20 minutes
Secondary outcomes (2)
Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.
Percentage of Participants with successfully placed lines with a complication
Measured: 24 hours
The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.
The median time it took an Emergency Physician from needle puncture to cannulation in minutes
Measured: Less than 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start18 Aug 2016
- Primary completion6 Sep 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for IV AccessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study utilizes a convenience sample of patient who have difficult venous access with at least 2 attempts by nursing to achieve venous access. The patient will be consented and a physician placed ultrasound-guided peripheral IV will be placed in the internal jugular vein.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center of Southern Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph (Tony) Zitek, MD, University Medical Center of Southern Nevada
- Investigators
- Joseph A Zitek, MD, Principal investigator, UMCSN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231345
- Sponsor's protocol ID
- 16.08.002
- Status last verified
- Jan 2019
- First submitted
- 22 Jul 2017
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
PubMed 26557487Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
PubMed 10577399Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
PubMed 18824276Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
PubMed 22579025Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.
PubMed 26469683Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.
PubMed 26776533Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.
PubMed 22033389Ash AJ, Raio C. Seldinger Technique for Placement of "Peripheral" Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.
PubMed 26823937
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Placement of Peripheral Intravenous Lines in the Internal Jugular Vein.
- ClinicalTrials.gov ID
- NCT03231345
- Acronym / sponsor ID
- 16.08.002
- Conditions
- IV Access
- Keywords
- Peripheral IV, Internal jugular vein, IJ, Peripheral IJ, Ultrasound-guided IJ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Medical Center of Southern NevadaUniversity, hospital or other
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Posted 15 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Difficult venous access in some patients such as those with obesity, IV drug use, chronic illness, or vascular pathology often causes increased discomfort and delayed patient care due to multiple attempts to gain venous access. If access is achieved at all, it usually results in a much smaller catheter than needed to provide optimal care for the patient. Ultrasound-guided placement of a peripheral IV in the internal jugular vein is common in the investigators' emergency department and is gaining popularity across the US. This study investigates the utility and safety of placing an ultrasound-guided peripheral IV catheter in the internal jugular vein.
Detailed description
Intravenous access in the emergency department (ED) patient is essential for medication delivery, IV fluid resuscitation, rapid serum laboratory diagnostics, and administration of IV contrast for CT scans. Some patients, such as those with obesity, IV drug abuse, chronic illnesses, or vascular pathology may have difficult IV access. These patients are problematic for the busy ED nurse and physician as this can lead to a time consuming process, which slows efficiency and patient care.
Previously, patients with difficult IV access often required central venous catheterization, a procedure that can result in a number of serious complications (1). More recently, ultrasound guidance has been touted as an effective means to achieve peripheral IV access on these patients (2). In one study (2), there was a 73% first attempt cannulation rate, which seems respectable, but not excellent. Additionally, 8% of the successful IVs failed within one hour (2). Another study compared ultrasonographically guided peripheral IVs to non-ultrasonographically guided IVs, and it found that using ultrasound did not decrease the amount of time or the number of attempts it took to successfully place a peripheral IV (3). Although ultrasound-guided peripheral IV's have a role, there remains room for improvement in being able to achieve rapid IV access in those patients who need IV access on an urgent basis.
It seems that we still have room to improve our ability to obtain difficult IV access, and a relatively new technique may be the answer. Ultrasound guided IVs are typically attempted in the upper extremities, targeting the brachial or basilic veins, but a recently described technique --- the "peripheral IJ" --- involves placement of a peripheral IV catheter in the internal jugular vein (4,5).
The peripheral IJ is gaining popularity in the investigators' ED as a solution to the difficult vascular access patient. In the investigators' clinical experience, it is a quick and easy procedure that is also safe, tolerated well by patients, and requires few resources. Several small studies have concluded that this is a fast and safe procedure and a feasible alternative to central access in the difficult vascular access patient (4-7). These studies mention the theoretical risks as being similar to central venous access such as carotid artery puncture, hematoma, pneumothorax, and line infection, however none of these have actually been reported (4-7). Therefore, we seek primarily to determine the average number of attempts to cannulation for ultrasound-guided peripheral IJ placement. Secondarily, we wish to determine: 1) the prevalence of potential complications related to this procedure 2) the average time it takes the emergency physician to complete the procedure 3) the patient's satisfaction with the procedure. We will compare the data from this study to the published data for other types of ultrasound-guided peripheral IVs.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study utilizes a convenience sample of patient who have difficult venous access with at least 2 attempts by nursing to achieve venous access. The patient will be consented and a physician placed ultrasound-guided peripheral IV will be placed in the internal jugular vein.
| Arm | Type | Receives |
|---|---|---|
| US guided IJ | Experimental | Procedure: US guided IJ, Device: UltrasoundA physician placed ultrasound-guided IV in the internal jugular vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 2 unsuccessful attempts at peripheral IV access by ED nursing
- Age 18 or older
Key exclusion criteria (6 listed)
- Critically ill patients with clinical indications for emergent central venous access.
- Overlying skin infection
- External jugular vein easily visible for cannulation
- Patient in law enforcement custody
- Patient who is known to be pregnant or self identifies as pregnant
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 |
|---|---|---|
| US guided IJAlso: Ultrasound-guided Internal Jugular veinIV catheter placement | Procedure or surgery | US guided IJ |
| UltrasoundUltrasound-guided Internal Jugular vein | Device | US guided IJ |
Primary outcome
Number of Participants With Successful Cannulation of the Internal Jugular Vein
Time frame: Less than 20 minutes
The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.
2 secondary outcomes
Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.
Time frame: 24 hours
The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.
Time frame: Less than 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26557487Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.
- Background: PubMed 10577399Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.
- Background: PubMed 18824276Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
- Background: PubMed 22579025Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
- Background: PubMed 26469683Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.
- Background: PubMed 26776533Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.
- Background: PubMed 22033389Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.
- Background: PubMed 26823937Ash AJ, Raio C. Seldinger Technique for Placement of "Peripheral" Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.
- Individual participant dataSharing planned: No
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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.
Joseph A Zitek, MD principal investigator
UMCSN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guided IJ and Ultrasound in people with IV Access, run by University Medical Center of Southern Nevada 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 6 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 15 Jan 2019. 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?
Yes. Results are posted in the registry (first posted 15 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Cannulation of the Internal Jugular Vein (time frame: Less than 20 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 NCT03231345, which also lists 8 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 15 Jan 2019.