Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

NCT01966354 | Completed Results DMC

• 1 other identifier: PI12/00679
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of three ultrasound assistance techniques for internal jugular venous cannulation, in terms of cannulation success and prevention of complications.

Conditions

Ultrasound-guided Internal Jugular Cannulation; Central Venous Access Complications

Keywords

adult; catheterization, central venous; ultrasonography, interventional; evidence-based medicine; cost-benefit analysis

Outcome Measures

Primary Outcomes (1)

• Cannulation Success

  Cannulation will be considered as "successful" once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered "unsuccessful". This outcome measure will be registered at the end of the cannulation process.

  At the end of the cannulation process (180 seconds, maximum)

Secondary Outcomes (5)

• Number of Cannulation Attempts

  At the end of the cannulation process (180 seconds, maximum)

• First Attempt Cannulation

  At the end of the cannulation process (180 seconds, maximum)

• Cannulation Time

  At the end of the cannulation process (180 seconds, maximum)

• Mechanical Complications

  At the end of the cannulation process (180 seconds, maximum)

• Infectious Complications

  Once the central venous catheter is withdrawn (2 months)

Study Arms (3)

Long axis, in-plane needle

EXPERIMENTAL

Ultrasound-guided Internal jugular venous approach Long axis, in-plane needle: Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.

Procedure: Ultrasound-guided Internal jugular venous approach

Short axis, out-of-plane needle

EXPERIMENTAL

Ultrasound-guided Internal jugular venous approach Short axis, out-of-plane needle: Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).

Procedure: Ultrasound-guided Internal jugular venous approach

Oblique axis, in-plane needle

EXPERIMENTAL

Ultrasound-guided Internal jugular venous approach Oblique axis, in-plane needle: Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.

Procedure: Ultrasound-guided Internal jugular venous approach

Interventions

Ultrasound-guided Internal jugular venous approach PROCEDURE

The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer. In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane).

Long axis, in-plane needle; Oblique axis, in-plane needle; Short axis, out-of-plane needle

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 or older
• Indication for internal jugular venous cannulation, previously established by the doctor responsible for the patient´s hospital diagnosis and treatment
• Informed consent for trial participation has been obtained from the patient

You may not qualify if:

• Infection signs at or close to puncture site
• Cutaneous erosions or subcutaneous haematoma at or close to puncture site
• History of internal jugular venous cannulation during the past 72 hours (in the same side in which the present cannulation is taking place)
• History of previous surgical interventions on the cannulation site
• Recent cervical trauma with present neck immobilization and without having ruled out eventual cervical spinal injury
• Severe coagulopathy (altered coagulation parameters and active bleeding) which cannot be promptly corrected by platelet, fresh frozen plasma or pharmacologic intervention
• Subcutaneous emphysema with cervical extension
• Agitated or uncooperative patient (including deep sedation)
• Inability to obtain formal informed consent from the patient or his legally authorized representative (in case the patient is legally incompetent to give informed consent)
• Cannulation being performed outside the surgical area or the post-anesthesia care unit

Sponsors & Collaborators

• Mikel Batllori: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Complejo Hospitalario de Navarra, Anesthesiology department

Pamplona, Navarre, 31008, Spain

Location

Related Publications (14)

• Eisen LA, Narasimhan M, Berger JS, Mayo PH, Rosen MJ, Schneider RF. Mechanical complications of central venous catheters. J Intensive Care Med. 2006 Jan-Feb;21(1):40-6. doi: 10.1177/0885066605280884.

  PMID: 16698743 BACKGROUND

• Maecken T, Grau T. Ultrasound imaging in vascular access. Crit Care Med. 2007 May;35(5 Suppl):S178-85. doi: 10.1097/01.CCM.0000260629.86351.A5.

  PMID: 17446777 BACKGROUND

• Karakitsos D, Labropoulos N, De Groot E, Patrianakos AP, Kouraklis G, Poularas J, Samonis G, Tsoutsos DA, Konstadoulakis MM, Karabinis A. Real-time ultrasound-guided catheterisation of the internal jugular vein: a prospective comparison with the landmark technique in critical care patients. Crit Care. 2006;10(6):R162. doi: 10.1186/cc5101.

  PMID: 17112371 BACKGROUND

• Milling TJ Jr, Rose J, Briggs WM, Birkhahn R, Gaeta TJ, Bove JJ, Melniker LA. Randomized, controlled clinical trial of point-of-care limited ultrasonography assistance of central venous cannulation: the Third Sonography Outcomes Assessment Program (SOAP-3) Trial. Crit Care Med. 2005 Aug;33(8):1764-9. doi: 10.1097/01.ccm.0000171533.92856.e5.

  PMID: 16096454 BACKGROUND

• Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.

  PMID: 12919984 BACKGROUND

• Shojania KG, Duncan BW, McDonald KM, Wachter RM, Markowitz AJ. Making health care safer: a critical analysis of patient safety practices. Evid Rep Technol Assess (Summ). 2001;(43):i-x, 1-668.

  PMID: 11510252 BACKGROUND

• Hessel EA 2nd. Con: we should not enforce the use of ultrasound as a standard of care for obtaining central venous access. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):725-8. doi: 10.1053/j.jvca.2009.06.020. No abstract available.

  PMID: 19789059 BACKGROUND

• Augoustides JG, Cheung AT. Pro: ultrasound should be the standard of care for central catheter insertion. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):720-4. doi: 10.1053/j.jvca.2009.06.012. Epub 2009 Aug 15. No abstract available.

  PMID: 19686963 BACKGROUND

• Blaivas M, Adhikari S. An unseen danger: frequency of posterior vessel wall penetration by needles during attempts to place internal jugular vein central catheters using ultrasound guidance. Crit Care Med. 2009 Aug;37(8):2345-9; quiz 2359. doi: 10.1097/CCM.0b013e3181a067d4.

  PMID: 19531950 BACKGROUND

• Moon CH, Blehar D, Shear MA, Uyehara P, Gaspari RJ, Arnold J, Cukor J. Incidence of posterior vessel wall puncture during ultrasound-guided vessel cannulation in a simulated model. Acad Emerg Med. 2010 Oct;17(10):1138-41. doi: 10.1111/j.1553-2712.2010.00869.x.

  PMID: 21069895 BACKGROUND

• Stone MB, Moon C, Sutijono D, Blaivas M. Needle tip visualization during ultrasound-guided vascular access: short-axis vs long-axis approach. Am J Emerg Med. 2010 Mar;28(3):343-7. doi: 10.1016/j.ajem.2008.11.022. Epub 2010 Jan 28.

  PMID: 20223394 BACKGROUND

• Chittoodan S, Breen D, O'Donnell BD, Iohom G. Long versus short axis ultrasound guided approach for internal jugular vein cannulation: a prospective randomised controlled trial. Med Ultrason. 2011 Mar;13(1):21-5.

  PMID: 21390339 BACKGROUND

• Phelan M, Hagerty D. The oblique view: an alternative approach for ultrasound-guided central line placement. J Emerg Med. 2009 Nov;37(4):403-8. doi: 10.1016/j.jemermed.2008.02.061. Epub 2008 Oct 1.

  PMID: 18829208 BACKGROUND

• Batllori M, Urra M, Uriarte E, Romero C, Pueyo J, Lopez-Olaondo L, Cambra K, Ibanez B. Randomized comparison of three transducer orientation approaches for ultrasound guided internal jugular venous cannulation. Br J Anaesth. 2016 Mar;116(3):370-6. doi: 10.1093/bja/aev399. Epub 2015 Dec 24.

  PMID: 26705350 DERIVED

Related Links

• Web of the investigation project in navarrabiomed. Click here for more information about this study.

Limitations and Caveats

Results may be only extrapolative to experienced cannulators

Results Point of Contact

• Title: Dr. Mikel Batllori
• Organization: Complejo Hospitalario de Navarra

mikel.batllori.gaston@cfnavarra.es

0034 848422174

Study Officials

• Mikel Batllori, MD

  Complejo Hospitalario de Navarra, Anesthesiology department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mikel Batllori Gaston, MD

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 21, 2013
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 1, 2016
• Results First Posted: June 28, 2016

Record last verified: 2016-06

Locations

ES (1)