Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation

NCT ID: NCT01966354

Last Updated: 2016-08-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ultrasound-guided Internal Jugular Cannulation Central Venous Access Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Long axis, in-plane needle

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.

Group Type EXPERIMENTAL

Ultrasound-guided Internal jugular venous approach

Intervention Type 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).

Short axis, out-of-plane needle

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).

Group Type EXPERIMENTAL

Ultrasound-guided Internal jugular venous approach

Intervention Type 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).

Oblique axis, in-plane needle

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.

Group Type EXPERIMENTAL

Ultrasound-guided Internal jugular venous approach

Intervention Type 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).

Interventions

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Ultrasound-guided Internal jugular venous approach

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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Mikel Batllori

OTHER

Sponsor Role lead

Responsible Party

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Mikel Batllori

Mikel Batllori Gaston, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mikel Batllori, MD

Role: STUDY_DIRECTOR

Complejo Hospitalario de Navarra, Anesthesiology department

Locations

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Complejo Hospitalario de Navarra, Anesthesiology department

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 16698743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17446777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17112371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16096454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12919984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11510252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19789059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19686963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19531950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21069895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20223394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21390339 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18829208 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26705350 (View on PubMed)

Related Links

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http://www.navarrabiomed.es

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

Other Identifiers

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PI12/00679

Identifier Type: -

Identifier Source: org_study_id

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