- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966354
Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation (OISO-1)
Comparison of Three Techniques for Ultrasound-guided Internal Jugular Cannulation: Long Axis, In-plane Needle v. Short Axis, Out-of-plane Needle v. Oblique Axis, In-plane Needle
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Navarra
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Pamplona, Navarra, Spain, 31008
- Complejo Hospitalario de Navarra, Anesthesiology department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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). |
Experimental: 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). |
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). |
Experimental: 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. |
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cannulation Success
Time Frame: At the end of the cannulation process (180 seconds, maximum)
|
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.
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At the end of the cannulation process (180 seconds, maximum)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Cannulation Attempts
Time Frame: At the end of the cannulation process (180 seconds, maximum)
|
Number of cannulation attempts that have taken place before cannulation success.
Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.
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At the end of the cannulation process (180 seconds, maximum)
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First Attempt Cannulation
Time Frame: At the end of the cannulation process (180 seconds, maximum)
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Any cannulation that has been accomplished with a single cannulation attempt will be considered a "first attempt cannulation".
This outcome measure will be registered at the end of the cannulation process.
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At the end of the cannulation process (180 seconds, maximum)
|
Cannulation Time
Time Frame: At the end of the cannulation process (180 seconds, maximum)
|
Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein.
This outcome measure will be registered at the end of the cannulation process.
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At the end of the cannulation process (180 seconds, maximum)
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Mechanical Complications
Time Frame: At the end of the cannulation process (180 seconds, maximum)
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The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement.
This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.
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At the end of the cannulation process (180 seconds, maximum)
|
Infectious Complications
Time Frame: Once the central venous catheter is withdrawn (2 months)
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The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn.
Patients will be followed for the duration of central venous access, an expected average of 8 weeks.
The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.
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Once the central venous catheter is withdrawn (2 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Mikel Batllori, MD, Complejo Hospitalario de Navarra, Anesthesiology department
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI12/00679
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