Central Venous CatheterizationBIUSNCT02741453
Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement
A study testing Standard Practice and Bilateral IJ Ultrasound Scanning in people with Central Venous Catheterization and Ultrasonography, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Central venous catheter placement is a common procedure in the intensive care unit and is a required skill for all residents working in the critical care setting. Central venous catheters (CVC) are placed for a variety of reasons including administration of caustic medications, administration of fluids or blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheterization, Ultrasonography, Critical Care
- What is being tested?
- Standard Practice and Bilateral IJ Ultrasound Scanning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 1 May 2017
- 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
- Patient admitted to the medical intensive care unit on the 8th floor
- Central venous catheter placed by a resident or nurse practitioner working in the medical intensive care unit
- Central venous catheter placed in the right or left internal jugular vein
- Central venous catheter placed with ultrasound guidance
Who cannot join
- Line placed outside the MICU
- Placed in the subclavian or femoral vein
- Placed by a fellow in training or attending physician
- Placed under emergent or time-sensitive conditions
- Placed during a code
- Placed under non-sterile conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Scanning of Bilateral Internal Jugular Veins With Ultrasound Prior to CVC Placement - Effect on Success and Complications
Central venous catheter placement is a common procedure in the intensive care unit and is a required skill for all residents working in the critical care setting. Central venous catheters (CVC) are placed for a variety of reasons including administration of caustic medications, administration of fluids or blood products for rapid resuscitation, access for hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or inability to obtain peripheral IV access. CVC's are routinely placed in the internal jugular vein in the Vanderbilt medical ICU and ultrasound guidance is used. Placement of the CVC on the right IJ instead of the left IJ is commonly preferred due to the more direct path to the superior vena cava. However, placement in the left IJ may be necessary for a variety of reasons. The investigators intend to compare the standard practice of residents and nurse practitioners placing IJ CVCs in the medical ICU against mandatory screening of the right and left IJ prior to selection of the CVC placement site. The investigators will accomplish this by assessing the relative first pass stick and overall success rates, the rate of aborted procedures, and the rate of complications between standard practice and mandatory screening of bilateral internal jugular veins prior to CVC site selection.
Read the detailed description
Central venous catheter placement is a common procedure in the intensive care unit and is a required skill for all residents working in the critical care setting. Central venous catheters (CVC) are placed for a variety of reasons including administration of caustic medications, administration of fluids or blood products for rapid resuscitation, access for hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or inability to obtain peripheral IV access.
The 2011 CDC Guidelines for Prevention of Intravascular Catheter-Related Infections recommends placement of a CVC in the subclavian vein rather than the internal jugular vein to minimize infection risk. However, due to lack of experience with placement in the subclavian vein, in the Vanderbilt MICU, it is most common for residents to place catheters in the internal jugular vein. Placement of the CVC under ultrasound guidance has become standard of care and is also recommended by the aforementioned CDC guidelines (CDC guidelines).
Ultrasound guidance for CVC placement has improved patient safety by reducing the rate of complications, improving success rates, and decreasing number of attempts and time for successful insertion (Brass). The benefit of ultrasound guidance in reducing complications is especially important when less experienced operators such as residents are placing a CVC (Rando, Airapetian, Dodge). The addition of an ultrasound machine to an otherwise sterile procedure does not increase the rate of catheter associated blood stream infections (Cartier).
Placement of the IJ CVC on the right instead of the left is commonly preferred due to the more direct path to the superior vena cava. However, placement in the left IJ may be necessary for a variety of reasons. Depending on head position, the degree of overlap between the right IJ and the right carotid artery may make right sided placement precarious due to risk of arterial puncture (Ozbek, Maecken). Previously undetected IJ thrombus on the right may also prevent CVC placement, requiring a switch to the contralateral side (Goel). Ultrasound guidance could also reveal a unilateral vascular anatomic anomaly that would otherwise complicate CVC insertion (Benter, Rossi).
For these reasons, the investigators intend to compare the standard practice of residents placing IJ CVC in the medical ICU against mandatory screening of the right and left IJ prior to selection of the CVC placement site.
The benefits of ultrasound guidance for IJ CVC placement are well established. However, the benefits of ultrasound guidance may be extended by more fully evaluating both the left and right IJ prior to choosing a side for placement. As mentioned previously, several factors could make placement of the CVC on a particular side either more successful or precarious. These factors include possible asymmetric diameter of the IJ vein, unfavorable relationship of the IJ to the carotid artery, pre-existing IJ thrombus, or other aberrant vascular anatomy.
This study will begin with a 4 month period of data collection on the standard practice of IJ CVC placement by residents in the medical intensive care unit. Data will be collected on the success rate of CVC insertion as measured by "first stick" placement of the catheter. The study will also record how often placement of the CVC must be aborted in favor of an attempt on the contralateral side. Any incidental detection of pre-existing conditions that could complicate CVC placement, including IJ thrombus or aberrant anatomy, will also be recorded. Finally, the investigators will record rates of immediate complication of CVC placement, including pneumothorax, hemothorax, and arterial placement or puncture of the CVC catheter.
In the medical ICU of the institution where this study will occur, nurse practitioners perform similar duties to residents on a separate but similarly operating ICU team. Data on central line placement by nurse practitioners will also be collected.
The specific aims will be threefold:
Specific Aim 1: To assess the first pass and overall success rates when both IJ veins are evaluated by ultrasound compared to standard IJ CVC placement by ultrasound.
Specific Aim 2: To assess the rate of aborted procedures between the two study periods, as defined by failure of catheter placement at the side of first needle puncture site or failure of catheter placement overall.
Specific Aim 3: To assess the rate of complications when IJ central venous catheters are placed after evaluation of bilateral IJ sites compared to current practice of placing IJ catheters under ultrasound guidance.
- Being tested
- Standard Practice, Bilateral IJ Ultrasound Scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PracticeProcedure or surgery
Bilateral IJ Ultrasound ScanningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Practice | Active comparator | Placement of a CVC by standard practice Receives: Procedure: Standard Practice |
| Bilateral IJ Ultrasound Scanning | Experimental | Placement of a CVC after mandatory ultrasound scanning of both right and left internal jugular veins Receives: Procedure: Bilateral IJ Ultrasound Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Success Rate
First pass success rate will be defined as access of the initially targeted internal jugular vein with the first pass of the guide needle.
Measured: 8 months
Secondary outcomes (3)
Success Rate
Success rate will be defined as successful placement of the central venous catheter at the initially targeted site.
Measured: 8 months
Aborted Procedure Rate
Aborted procedure will be defined as failure to place the catheter at side of first needle puncture site or failure of catheter placement overall.
Measured: 8 months
Complication Rate
Complications will include but will not be confined to the following:
- Catheter related infection
- Catheter related thrombosis
- Injury to adjacent vascular structures
- Arterial placement of central venous catheter
- Arrhythmia induced by catheter placement
- Violation of the pleural space resulting in pneumothorax or hemothorax
- Venous air embolism
- Uncontrolled bleeding from placement including bleeding compromising the airway
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Story, Vanderbilt University Medical Center
- Investigators
- Ryan Story, MD, Principal investigator, Vanderbilt University Medical CenterTodd Rice, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741453
- Sponsor's protocol ID
- 160704
- Acronym
- BIUS
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2016
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
PubMed 21511081Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD011447. doi: 10.1002/14651858.CD011447.
PubMed 25575245Rando K, Castelli J, Pratt JP, Scavino M, Rey G, Rocca ME, Zunini G. Ultrasound-guided internal jugular vein catheterization: a randomized controlled trial. Heart Lung Vessel. 2014;6(1):13-23.
PubMed 24800194Airapetian N, Maizel J, Langelle F, Modeliar SS, Karakitsos D, Dupont H, Slama M. Ultrasound-guided central venous cannulation is superior to quick-look ultrasound and landmark methods among inexperienced operators: a prospective randomized study. Intensive Care Med. 2013 Nov;39(11):1938-44. doi: 10.1007/s00134-013-3072-z. Epub 2013 Sep 12.
PubMed 24026296Dodge KL, Lynch CA, Moore CL, Biroscak BJ, Evans LV. Use of ultrasound guidance improves central venous catheter insertion success rates among junior residents. J Ultrasound Med. 2012 Oct;31(10):1519-26. doi: 10.7863/jum.2012.31.10.1519.
PubMed 23011614Cartier V, Haenny A, Inan C, Walder B, Zingg W. No association between ultrasound-guided insertion of central venous catheters and bloodstream infection: a prospective observational study. J Hosp Infect. 2014 Jun;87(2):103-8. doi: 10.1016/j.jhin.2014.03.009. Epub 2014 Apr 13.
PubMed 24811115Ozbek S, Apiliogullari S, Kivrak AS, Kara I, Saltali AO. Relationship between the right internal jugular vein and carotid artery at ipsilateral head rotation. Ren Fail. 2013;35(5):761-5. doi: 10.3109/0886022X.2013.789970. Epub 2013 May 7.
PubMed 23650892Maecken T, Marcon C, Bomas S, Zenz M, Grau T. Relationship of the internal jugular vein to the common carotid artery: implications for ultrasound-guided vascular access. Eur J Anaesthesiol. 2011 May;28(5):351-5. doi: 10.1097/EJA.0b013e328341a492.
PubMed 21150630Goel S, Majhi S, Panigrahi B. Unexpected detection of internal jugular vein thrombus during ultrasound-guided central venous cannulation. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):e36-7. doi: 10.1053/j.jvca.2011.03.177. Epub 2011 Jun 8. No abstract available.
PubMed 21641820Benter T, Teichgraber UK, Kluhs L, Papadopoulos S, Kohne CH, Felix R, Dorken B. Anatomical variations in the internal jugular veins of cancer patients affecting central venous access. Anatomical variation of the internal jugular vein. Ultraschall Med. 2001 Feb;22(1):23-6. doi: 10.1055/s-2001-11243.
PubMed 11253552Rossi UG, Rigamonti P, Torcia P, Mauri G, Brunini F, Rossi M, Gallieni M, Cariati M. Congenital anomalies of superior vena cava and their implications in central venous catheterization. J Vasc Access. 2015 Jul-Aug;16(4):265-8. doi: 10.5301/jva.5000371. Epub 2015 Mar 9.
PubMed 25768048
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scanning of Bilateral Internal Jugular Veins With Ultrasound Prior to CVC Placement - Effect on Success and Complications
- ClinicalTrials.gov ID
- NCT02741453
- Acronym / sponsor ID
- BIUS / 160704
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 18 Apr 2016 (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.
Central venous catheter placement is a common procedure in the intensive care unit and is a required skill for all residents working in the critical care setting. Central venous catheters (CVC) are placed for a variety of reasons including administration of caustic medications, administration of fluids or blood products for rapid resuscitation, access for hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or inability to obtain peripheral IV access. CVC's are routinely placed in the internal jugular vein in the Vanderbilt medical ICU and ultrasound guidance is used. Placement of the CVC on the right IJ instead of the left IJ is commonly preferred due to the more direct path to the superior vena cava. However, placement in the left IJ may be necessary for a variety of reasons. The investigators intend to compare the standard practice of residents and nurse practitioners placing IJ CVCs in the medical ICU against mandatory screening of the right and left IJ prior to selection of the CVC placement site. The investigators will accomplish this by assessing the relative first pass stick and overall success rates, the rate of aborted procedures, and the rate of complications between standard practice and mandatory screening of bilateral internal jugular veins prior to CVC site selection.
Detailed description
Central venous catheter placement is a common procedure in the intensive care unit and is a required skill for all residents working in the critical care setting. Central venous catheters (CVC) are placed for a variety of reasons including administration of caustic medications, administration of fluids or blood products for rapid resuscitation, access for hemodynamic monitoring or transvenous pacing, temporary vascular access for dialysis, or inability to obtain peripheral IV access.
The 2011 CDC Guidelines for Prevention of Intravascular Catheter-Related Infections recommends placement of a CVC in the subclavian vein rather than the internal jugular vein to minimize infection risk. However, due to lack of experience with placement in the subclavian vein, in the Vanderbilt MICU, it is most common for residents to place catheters in the internal jugular vein. Placement of the CVC under ultrasound guidance has become standard of care and is also recommended by the aforementioned CDC guidelines (CDC guidelines).
Ultrasound guidance for CVC placement has improved patient safety by reducing the rate of complications, improving success rates, and decreasing number of attempts and time for successful insertion (Brass). The benefit of ultrasound guidance in reducing complications is especially important when less experienced operators such as residents are placing a CVC (Rando, Airapetian, Dodge). The addition of an ultrasound machine to an otherwise sterile procedure does not increase the rate of catheter associated blood stream infections (Cartier).
Placement of the IJ CVC on the right instead of the left is commonly preferred due to the more direct path to the superior vena cava. However, placement in the left IJ may be necessary for a variety of reasons. Depending on head position, the degree of overlap between the right IJ and the right carotid artery may make right sided placement precarious due to risk of arterial puncture (Ozbek, Maecken). Previously undetected IJ thrombus on the right may also prevent CVC placement, requiring a switch to the contralateral side (Goel). Ultrasound guidance could also reveal a unilateral vascular anatomic anomaly that would otherwise complicate CVC insertion (Benter, Rossi).
For these reasons, the investigators intend to compare the standard practice of residents placing IJ CVC in the medical ICU against mandatory screening of the right and left IJ prior to selection of the CVC placement site.
The benefits of ultrasound guidance for IJ CVC placement are well established. However, the benefits of ultrasound guidance may be extended by more fully evaluating both the left and right IJ prior to choosing a side for placement. As mentioned previously, several factors could make placement of the CVC on a particular side either more successful or precarious. These factors include possible asymmetric diameter of the IJ vein, unfavorable relationship of the IJ to the carotid artery, pre-existing IJ thrombus, or other aberrant vascular anatomy.
This study will begin with a 4 month period of data collection on the standard practice of IJ CVC placement by residents in the medical intensive care unit. Data will be collected on the success rate of CVC insertion as measured by "first stick" placement of the catheter. The study will also record how often placement of the CVC must be aborted in favor of an attempt on the contralateral side. Any incidental detection of pre-existing conditions that could complicate CVC placement, including IJ thrombus or aberrant anatomy, will also be recorded. Finally, the investigators will record rates of immediate complication of CVC placement, including pneumothorax, hemothorax, and arterial placement or puncture of the CVC catheter.
In the medical ICU of the institution where this study will occur, nurse practitioners perform similar duties to residents on a separate but similarly operating ICU team. Data on central line placement by nurse practitioners will also be collected.
The specific aims will be threefold:
Specific Aim 1: To assess the first pass and overall success rates when both IJ veins are evaluated by ultrasound compared to standard IJ CVC placement by ultrasound.
Specific Aim 2: To assess the rate of aborted procedures between the two study periods, as defined by failure of catheter placement at the side of first needle puncture site or failure of catheter placement overall.
Specific Aim 3: To assess the rate of complications when IJ central venous catheters are placed after evaluation of bilateral IJ sites compared to current practice of placing IJ catheters under ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | Active comparator | Procedure: Standard PracticePlacement of a CVC by standard practice |
| Bilateral IJ Ultrasound Scanning | Experimental | Procedure: Bilateral IJ Ultrasound ScanningPlacement of a CVC after mandatory ultrasound scanning of both right and left internal jugular veins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient admitted to the medical intensive care unit on the 8th floor
- Central venous catheter placed by a resident or nurse practitioner working in the medical intensive care unit
- Central venous catheter placed in the right or left internal jugular vein
- Central venous catheter placed with ultrasound guidance
Key exclusion criteria (6 listed)
- Line placed outside the MICU
- Placed in the subclavian or femoral vein
- Placed by a fellow in training or attending physician
- Placed under emergent or time-sensitive conditions
- Placed during a code
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 |
|---|---|---|
| Standard Practice | Procedure or surgery | Standard Practice |
| Bilateral IJ Ultrasound Scanning | Procedure or surgery | Bilateral IJ Ultrasound Scanning |
Primary outcome
First Pass Success Rate
Time frame: 8 months
First pass success rate will be defined as access of the initially targeted internal jugular vein with the first pass of the guide needle.
3 secondary outcomes
Success Rate
Time frame: 8 months
Aborted Procedure Rate
Time frame: 8 months
Complication Rate
Time frame: 8 months
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 14 Jul 2017.
- Background: PubMed 21511081O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
- Background: PubMed 25575245Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD011447. doi: 10.1002/14651858.CD011447.
- Background: PubMed 24800194Rando K, Castelli J, Pratt JP, Scavino M, Rey G, Rocca ME, Zunini G. Ultrasound-guided internal jugular vein catheterization: a randomized controlled trial. Heart Lung Vessel. 2014;6(1):13-23.
- Background: PubMed 24026296Airapetian N, Maizel J, Langelle F, Modeliar SS, Karakitsos D, Dupont H, Slama M. Ultrasound-guided central venous cannulation is superior to quick-look ultrasound and landmark methods among inexperienced operators: a prospective randomized study. Intensive Care Med. 2013 Nov;39(11):1938-44. doi: 10.1007/s00134-013-3072-z. Epub 2013 Sep 12.
- Background: PubMed 23011614Dodge KL, Lynch CA, Moore CL, Biroscak BJ, Evans LV. Use of ultrasound guidance improves central venous catheter insertion success rates among junior residents. J Ultrasound Med. 2012 Oct;31(10):1519-26. doi: 10.7863/jum.2012.31.10.1519.
- Background: PubMed 24811115Cartier V, Haenny A, Inan C, Walder B, Zingg W. No association between ultrasound-guided insertion of central venous catheters and bloodstream infection: a prospective observational study. J Hosp Infect. 2014 Jun;87(2):103-8. doi: 10.1016/j.jhin.2014.03.009. Epub 2014 Apr 13.
- Background: PubMed 23650892Ozbek S, Apiliogullari S, Kivrak AS, Kara I, Saltali AO. Relationship between the right internal jugular vein and carotid artery at ipsilateral head rotation. Ren Fail. 2013;35(5):761-5. doi: 10.3109/0886022X.2013.789970. Epub 2013 May 7.
- Background: PubMed 21150630Maecken T, Marcon C, Bomas S, Zenz M, Grau T. Relationship of the internal jugular vein to the common carotid artery: implications for ultrasound-guided vascular access. Eur J Anaesthesiol. 2011 May;28(5):351-5. doi: 10.1097/EJA.0b013e328341a492.
- Background: PubMed 21641820Goel S, Majhi S, Panigrahi B. Unexpected detection of internal jugular vein thrombus during ultrasound-guided central venous cannulation. J Cardiothorac Vasc Anesth. 2011 Oct;25(5):e36-7. doi: 10.1053/j.jvca.2011.03.177. Epub 2011 Jun 8. No abstract available.
- Background: PubMed 11253552Benter T, Teichgraber UK, Kluhs L, Papadopoulos S, Kohne CH, Felix R, Dorken B. Anatomical variations in the internal jugular veins of cancer patients affecting central venous access. Anatomical variation of the internal jugular vein. Ultraschall Med. 2001 Feb;22(1):23-6. doi: 10.1055/s-2001-11243.
- Background: PubMed 25768048Rossi UG, Rigamonti P, Torcia P, Mauri G, Brunini F, Rossi M, Gallieni M, Cariati M. Congenital anomalies of superior vena cava and their implications in central venous catheterization. J Vasc Access. 2015 Jul-Aug;16(4):265-8. doi: 10.5301/jva.5000371. Epub 2015 Mar 9.
- 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.
Ryan Story, MD principal investigator
Vanderbilt University Medical Center
Todd Rice, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Practice and Bilateral IJ Ultrasound Scanning in people with Central Venous Catheterization and Ultrasonography, run by Vanderbilt University Medical Center 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 4 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 14 Jul 2017. 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?
First Pass Success Rate (time frame: 8 months). 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 NCT02741453, which also lists 11 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 14 Jul 2017.