Ultrasound-guided Peripheral IJ Study

NCT03231345 | Completed Results FDA Device

• 1 other identifier: 16.08.002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IV Access

Keywords

Peripheral IV; Internal jugular vein; IJ; Peripheral IJ; Ultrasound-guided IJ

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Cannulation of the Internal Jugular Vein

  The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.

  Less than 20 minutes

Secondary Outcomes (2)

• Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.

  24 hours

• The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.

  Less than 20 minutes

Study Arms (1)

US guided IJ

EXPERIMENTAL

A physician placed ultrasound-guided IV in the internal jugular vein

Procedure: US guided IJ; Device: Ultrasound

Interventions

US guided IJ PROCEDURE

IV catheter placement

Also known as: Ultrasound-guided Internal Jugular vein

US guided IJ

Ultrasound DEVICE

Ultrasound-guided Internal Jugular vein

US guided IJ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center of Southern Nevada: lead

Study Sites (1)

University Medical Center of Southen Nevada

Las Vegas, Nevada, 89102, United States

Location

Related Publications (8)

• Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.

  PMID: 26557487 BACKGROUND

• Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8.

  PMID: 10577399 BACKGROUND

• Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.

  PMID: 18824276 BACKGROUND

• Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.

  PMID: 22579025 BACKGROUND

• Butterfield M, Abdelghani R, Mohamad M, Limsuwat C, Kheir F. Using Ultrasound-Guided Peripheral Catheterization of the Internal Jugular Vein in Patients With Difficult Peripheral Access. Am J Ther. 2017 Nov/Dec;24(6):e667-e669. doi: 10.1097/MJT.0000000000000357.

  PMID: 26469683 BACKGROUND

• Kiefer D, Keller SM, Weekes A. Prospective evaluation of ultrasound-guided short catheter placement in internal jugular veins of difficult venous access patients. Am J Emerg Med. 2016 Mar;34(3):578-81. doi: 10.1016/j.ajem.2015.11.069. Epub 2015 Dec 4.

  PMID: 26776533 BACKGROUND

• Zwank MD. Ultrasound-guided catheter-over-needle internal jugular vein catheterization. Am J Emerg Med. 2012 Feb;30(2):372-3. doi: 10.1016/j.ajem.2011.08.013. Epub 2011 Oct 26. No abstract available.

  PMID: 22033389 BACKGROUND

• Ash AJ, Raio C. Seldinger Technique for Placement of "Peripheral" Internal Jugular Line: Novel Approach for Emergent Vascular Access. West J Emerg Med. 2016 Jan;17(1):81-3. doi: 10.5811/westjem.2015.11.28726. Epub 2016 Jan 12.

  PMID: 26823937 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Zitek
• Organization: University Medical Center of Southern Nevada

zitek10@gmail.com

702-383-7885

Study Officials

• Joseph A Zitek, MD

  UMCSN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Research Director, Emergency Medicine Residency Program

Model Details: This study utilizes a convenience sample of patient who have difficult venous access with at least 2 attempts by nursing to achieve venous access. The patient will be consented and a physician placed ultrasound-guided peripheral IV will be placed in the internal jugular vein.

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: July 27, 2017
• Study Start: August 18, 2016
• Primary Completion: September 6, 2017
• Study Completion: May 1, 2018
• Last Updated: January 15, 2019
• Results First Posted: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)