NCT02741453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

April 14, 2016

Last Update Submit

July 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Success Rate

    8 months

  • Aborted Procedure Rate

    8 months

  • Complication Rate

    8 months

Study Arms (2)

Standard Practice

ACTIVE COMPARATOR

Placement of a CVC by standard practice

Procedure: Standard Practice

Bilateral IJ Ultrasound Scanning

EXPERIMENTAL

Placement of a CVC after mandatory ultrasound scanning of both right and left internal jugular veins

Procedure: Bilateral IJ Ultrasound Scanning

Interventions

Standard Practice
Bilateral IJ Ultrasound Scanning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (11)

  • 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.

    PMID: 21511081BACKGROUND
  • 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(1):CD011447. doi: 10.1002/14651858.CD011447.

    PMID: 25575245BACKGROUND
  • 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.

    PMID: 24800194BACKGROUND
  • 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.

    PMID: 24026296BACKGROUND
  • 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. doi: 10.7863/jum.2012.31.10.1519.

    PMID: 23011614BACKGROUND
  • 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.

    PMID: 24811115BACKGROUND
  • 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.

    PMID: 23650892BACKGROUND
  • 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.

    PMID: 21150630BACKGROUND
  • 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. No abstract available.

    PMID: 21641820BACKGROUND
  • Benter 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.

    PMID: 11253552BACKGROUND
  • 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.

    PMID: 25768048BACKGROUND

Study Officials

  • Ryan Story, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
  • Todd Rice, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 18, 2016

Study Start

September 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations