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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cannulation Attempts | 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. | At the end of the cannulation process (180 seconds, maximum) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikel Batllori, MD | Complejo Hospitalario de Navarra, Anesthesiology department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario de Navarra, Anesthesiology department | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16698743 | Background | 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. | |
| 17446777 | 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. |
| Label | URL |
|---|---|
| Web of the investigation project in navarrabiomed. Click here for more information about this study. | View source |
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The day before IJVC was to be performed, patients (aged 18 or above) in whom IJVC had been indicated were asked to participate in the study. Patients who did not meet any exclusion criteria were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | 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). 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). |
| FG002 | 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | At the end of the cannulation process (180 seconds, maximum) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Catheter-related blood stream infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Posterior internal jugular venous wall puncture | Vascular disorders | Non-systematic Assessment |
Results may be only extrapolative to experienced cannulators
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mikel Batllori | Complejo Hospitalario de Navarra | 0034 848422174 | mikel.batllori.gaston@cfnavarra.es |
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|
| First Attempt Cannulation | 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. | At the end of the cannulation process (180 seconds, maximum) |
| Cannulation Time | 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. | At the end of the cannulation process (180 seconds, maximum) |
| Mechanical Complications | 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. | At the end of the cannulation process (180 seconds, maximum) |
| Infectious Complications | 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. | Once the central venous catheter is withdrawn (2 months) |
| 17112371 | 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. |
| 16096454 | 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. |
| 12919984 | 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. |
| 11510252 | 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. |
| 19789059 | 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. |
| 19686963 | 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. |
| 19531950 | 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. |
| 21069895 | 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. |
| 20223394 | 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. |
| 21390339 | 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. |
| 18829208 | 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. |
| 26705350 | Derived | 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. |
| BG001 | 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). 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). |
| BG002 | 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. 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). |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cannulated IJV diameter (cm) | Mean | Standard Deviation | centimeters (cm) |
|
| OG001 | 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). 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). |
| OG002 | 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. 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). |
|
|
| Secondary | Number of Cannulation Attempts | 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. | Posted | Mean | Standard Deviation | attempts | At the end of the cannulation process (180 seconds, maximum) |
|
|
|
| Secondary | First Attempt Cannulation | 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. | Posted | Number | participants | At the end of the cannulation process (180 seconds, maximum) |
|
|
|
| Secondary | Cannulation Time | 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. | Posted | Mean | Standard Deviation | seconds | At the end of the cannulation process (180 seconds, maximum) |
|
|
|
| Secondary | Mechanical Complications | 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. | Posted | Number | participants | At the end of the cannulation process (180 seconds, maximum) |
|
|
|
| Secondary | Infectious Complications | 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. | Posted | Number | participants | Once the central venous catheter is withdrawn (2 months) |
|
|
|
| 2 |
| 75 |
| 5 |
| 75 |
| EG001 | 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). 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). | 0 | 73 | 11 | 73 |
| EG002 | 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. 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). | 0 | 72 | 5 | 72 |
| Puncture site bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Local cervical haematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Catheter misplacement | Vascular disorders | Systematic Assessment |
|
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