Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02741453
Other study ID # 160704
Secondary ID
Status Completed
Phase N/A
First received April 14, 2016
Last updated July 11, 2017
Start date September 1, 2016
Est. completion date May 1, 2017

Study information

Verified date July 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

Procedure:
Standard Practice

Bilateral IJ Ultrasound Scanning


Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

Airapetian 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. — View Citation

Benter T, Teichgräber UK, Klühs L, Papadopoulos S, Köhne CH, Felix R, Dörken 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. — View Citation

Brass 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:CD011447. doi: 10.1002/14651858.CD011447. Review. — View Citation

Cartier 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. — View Citation

Dodge 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. — View Citation

Goel 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. — View Citation

Maecken 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. — View Citation

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. — View Citation

Ozbek 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. — View Citation

Rando 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. — View Citation

Rossi 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 months
Secondary Success Rate Success rate will be defined as successful placement of the central venous catheter at the initially targeted site. 8 months
Secondary 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. 8 months
Secondary 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
8 months
See also
  Status Clinical Trial Phase
Recruiting NCT05114551 - ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
Completed NCT05547646 - The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT02922101 - Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care N/A
Completed NCT02902783 - DONATE-Pilot Study on ICU Management of Deceased Organ Donors
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01857986 - Evaluating Air Leak Detection in Intubated Patients N/A
Recruiting NCT05518955 - VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU N/A
Recruiting NCT03810768 - Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Completed NCT03295630 - Validity of an Actigraph Accelerometer Following Critical Illness N/A
Completed NCT05556811 - HEaling LIght Algorithms for the ICU Patient N/A
Recruiting NCT05702411 - Air Stacking Technique For Pulmonary Reexpansion N/A
Recruiting NCT04979897 - Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
Completed NCT05281224 - Ventilator Tube Holder for Patients With a Tracheostomy
Withdrawn NCT02970903 - VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU N/A
Recruiting NCT02587273 - The Pharmacokinetics of Fentanyl in Intensive Care Patients Phase 4
Completed NCT02661607 - Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement N/A
Completed NCT01479153 - Venous Site for Central Catheterization N/A
Recruiting NCT06110390 - High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients N/A
Not yet recruiting NCT05593380 - The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH N/A