Comparison of Bedside Ultrasound With Chest X-ray for Confirmation of Central Venous Catheter Position

NCT02959203 | Completed

• 1 other identifier: 2016.053
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Insertion of a central venous catheter (CVC) could lead to a variety of complications. To detect those complications, Chest X-ray (CXR) is still the reference standard. However, there are major limitations in performing CXR's in the critical care setting. Aim/objectives: The objective of this study is to compare the use of bedside ultrasound (US) to conventional CXR in visualization of accuracy and safety of the CVC placement. The aim is to eventually replace X-ray with bedside ultrasound as gold standard for the confirmation of CVC-placement in critically ill patients, thereby reducing radiation exposure and unnecessary delay before CVC use. Methods: The bedside US will be performed by the student or attending physician, who is blinded for CXR findings. After US examination, the attending physician (or student) will fill in a structured form, based on an established protocol. CXR will be performed before or after US examination and assessed by a radiologist. The radiologist will be blinded for the findings of the bedside ultrasound to prevent any biases. Final diagnosis will be determined after examination of the complete medical chart.

Conditions

Pneumothorax Iatrogenic Postprocedural; Malposition, Central Venous Catheter

Keywords

Central Venous Catheter; Ultrasound; Chest X-ray; Pneumothorax

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of ultrasound to detect CVC malposition

  Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) are used as accuracy outcome parameters. A 'true positive' result is defined as an US-suggested aberrant position of the CVC (catheter tip in any other vein than the superior vena cava (SVC), outside the venous system, or positioned deep in the right atrium or ventricle) confirmed by CXR. If bedside US rules out an aberrant position of the catheter tip correctly it is considered to be a 'true negative' result

  Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)

Secondary Outcomes (2)

• Feasibility of ultrasound

  Feasiblity will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)

• Diagnostic accuracy of ultrasound to detect pneumothorax

  Accuracy will be measured after ultrasound and Chest X-ray evaluation (expected time frame: 3 hours)

Eligibility Criteria

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

Study Population

Patients who undergo central venous cannulation

You may qualify if:

• Age above 18
• Central venous cannulation performed
• CVC in internal jugular vein or subclavian vein

You may not qualify if:

• Refusal to undergo ultrasound examination
• Refusal to undergo chest X-ray
• CVC in femoral vein
• PICC

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Groene Hart Ziekenhuis: collaborator

Study Sites (1)

VU University Medical Center

Amsterdam, North Holland, 1081 HZ, Netherlands

Location

Related Publications (16)

• Hourmozdi JJ, Markin A, Johnson B, Fleming PR, Miller JB. Routine Chest Radiography Is Not Necessary After Ultrasound-Guided Right Internal Jugular Vein Catheterization. Crit Care Med. 2016 Sep;44(9):e804-8. doi: 10.1097/CCM.0000000000001737.

  PMID: 27035241 BACKGROUND

• Lalu MM, Fayad A, Ahmed O, Bryson GL, Fergusson DA, Barron CC, Sullivan P, Thompson C; Canadian Perioperative Anesthesia Clinical Trials Group. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis. Crit Care Med. 2015 Jul;43(7):1498-507. doi: 10.1097/CCM.0000000000000973.

  PMID: 25803646 BACKGROUND

• Lichtenstein D, van Hooland S, Elbers P, Malbrain ML. Ten good reasons to practice ultrasound in critical care. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):323-35. doi: 10.5603/AIT.2014.0056.

  PMID: 25432552 BACKGROUND

• Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

  PMID: 26398070 BACKGROUND

• Zadeh MK, Shirvani A. The role of routine chest radiography for detecting complications after central venous catheter insertion. Saudi J Kidney Dis Transpl. 2014 Sep;25(5):1011-6. doi: 10.4103/1319-2442.139895.

  PMID: 25193899 BACKGROUND

• Vezzani A, Manca T, Vercelli A, Braghieri A, Magnacavallo A. Ultrasonography as a guide during vascular access procedures and in the diagnosis of complications. J Ultrasound. 2013 Oct 29;16(4):161-70. doi: 10.1007/s40477-013-0046-5. eCollection 2013 Oct 29.

  PMID: 24432170 BACKGROUND

• Nayeemuddin M, Pherwani AD, Asquith JR. Imaging and management of complications of central venous catheters. Clin Radiol. 2013 May;68(5):529-44. doi: 10.1016/j.crad.2012.10.013. Epub 2013 Feb 13.

  PMID: 23415017 BACKGROUND

• Wirsing M, Schummer C, Neumann R, Steenbeck J, Schmidt P, Schummer W. Is traditional reading of the bedside chest radiograph appropriate to detect intraatrial central venous catheter position? Chest. 2008 Sep;134(3):527-533. doi: 10.1378/chest.07-2687. Epub 2008 Jul 18.

  PMID: 18641117 BACKGROUND

• Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.

  PMID: 17414086 BACKGROUND

• McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.

  PMID: 12646670 BACKGROUND

• Bedel J, Vallee F, Mari A, Riu B, Planquette B, Geeraerts T, Genestal M, Minville V, Fourcade O. Guidewire localization by transthoracic echocardiography during central venous catheter insertion: a periprocedural method to evaluate catheter placement. Intensive Care Med. 2013 Nov;39(11):1932-7. doi: 10.1007/s00134-013-3097-3. Epub 2013 Sep 20.

  PMID: 24052186 BACKGROUND

• Cortellaro F, Mellace L, Paglia S, Costantino G, Sher S, Coen D. Contrast enhanced ultrasound vs chest x-ray to determine correct central venous catheter position. Am J Emerg Med. 2014 Jan;32(1):78-81. doi: 10.1016/j.ajem.2013.10.001. Epub 2013 Oct 9.

  PMID: 24184012 BACKGROUND

• Vezzani A, Brusasco C, Palermo S, Launo C, Mergoni M, Corradi F. Ultrasound localization of central vein catheter and detection of postprocedural pneumothorax: an alternative to chest radiography. Crit Care Med. 2010 Feb;38(2):533-8. doi: 10.1097/CCM.0b013e3181c0328f.

  PMID: 19829102 BACKGROUND

• Gekle R, Dubensky L, Haddad S, Bramante R, Cirilli A, Catlin T, Patel G, D'Amore J, Slesinger TL, Raio C, Modayil V, Nelson M. Saline Flush Test: Can Bedside Sonography Replace Conventional Radiography for Confirmation of Above-the-Diaphragm Central Venous Catheter Placement? J Ultrasound Med. 2015 Jul;34(7):1295-9. doi: 10.7863/ultra.34.7.1295.

  PMID: 26112633 BACKGROUND

• Kim SC, Graff I, Sommer A, Hoeft A, Weber S. Ultrasound-guided supraclavicular central venous catheter tip positioning via the right subclavian vein using a microconvex probe. J Vasc Access. 2016 Sep 21;17(5):435-9. doi: 10.5301/jva.5000518. Epub 2016 Mar 22.

  PMID: 27012271 BACKGROUND

• Maury E, Guglielminotti J, Alzieu M, Guidet B, Offenstadt G. Ultrasonic examination: an alternative to chest radiography after central venous catheter insertion? Am J Respir Crit Care Med. 2001 Aug 1;164(3):403-5. doi: 10.1164/ajrccm.164.3.2009042.

  PMID: 11500340 BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 9, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

NL (1)