Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement (BIUS)

July 11, 2017 updated by: Ryan Story, Vanderbilt University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Practice
Placement of a CVC by standard practice
Procedure: Standard Practice
EXPERIMENTAL: Bilateral IJ Ultrasound Scanning
Placement of a CVC after mandatory ultrasound scanning of both right and left internal jugular veins
Procedure: Bilateral IJ Ultrasound Scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: 8 months
Success rate will be defined as successful placement of the central venous catheter at the initially targeted site.
8 months
Aborted Procedure Rate
Time Frame: 8 months
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
Complication Rate
Time Frame: 8 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Ryan Story, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (ESTIMATE)

April 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 160704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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