Ultrasound-guided Peripheral IJ Study

January 10, 2019 updated by: Joseph (Tony) Zitek, MD, University Medical Center of Southern Nevada

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

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
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southen Nevada

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:

  • At least 2 unsuccessful attempts at peripheral IV access by ED nursing
  • Age 18 or older

Exclusion Criteria:

  • 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

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: US guided IJ
A physician placed ultrasound-guided IV in the internal jugular vein
Procedure: US guided IJ
IV catheter placement
Other Names:
  • Ultrasound-guided Internal Jugular vein
Device: Ultrasound
Ultrasound-guided Internal Jugular vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Less than 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.
Time Frame: 24 hours
Percentage of Participants with successfully placed lines with a complication
24 hours
The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.
Time Frame: Less than 20 minutes
The median time it took an Emergency Physician from needle puncture to cannulation in minutes
Less than 20 minutes

Collaborators and Investigators

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

Sponsor

University Medical Center of Southern Nevada

Investigators

  • Principal Investigator: Joseph A Zitek, MD, UMCSN

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)

August 18, 2016

Primary Completion (Actual)

September 6, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

July 22, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16.08.002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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