Femoral Central Venous Access Comparison of 2 Methods

NCT02318940 | Completed Results

• 1 other identifier: HRR001
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the effectiveness and safety of the installation of femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark method

Conditions

Child

Keywords

ultrasound guided; femoral vein; central venous catheter; pediatric

Outcome Measures

Primary Outcomes (1)

• Installation on the First Try

  Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle

  intraoperative, an average of 1 hour

Secondary Outcomes (3)

• Successful Installation

  intraoperative, an average of 1 hour

• Number of Attempts

  intraoperative, an average of 1 hour

• Arterial Puncture

  intraoperative, an average of 1 hour

Study Arms (2)

Landmark method

OTHER

installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks. access will be through the femoral vein only

Device: central venous catheter

Ultrasound method

ACTIVE COMPARATOR

installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only

Device: central venous catheter

Interventions

central venous catheter DEVICE

installation of Central venous catheter ultrasound guided

Ultrasound method

Eligibility Criteria

• Age: 1 Week - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Need for central venous access

You may not qualify if:

• More than 15 years.
• Local infection at the puncture site
• Anatomical and / or functional vascular alteration known

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

Hospital Exequiel González Cortés

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Hospital Roberto del Rio

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Related Publications (23)

• Wu SY, Ling Q, Cao LH, Wang J, Xu MX, Zeng WA. Real-time two-dimensional ultrasound guidance for central venous cannulation: a meta-analysis. Anesthesiology. 2013 Feb;118(2):361-75. doi: 10.1097/ALN.0b013e31827bd172.

  PMID: 23249991 BACKGROUND

• National Institute for Clinical Excellence. Guidance on the use of ultrasound locating devices for placing central venous catheters. Technology Appraisal Guidance-No.49, 2002:1-21

  BACKGROUND

• American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.

  PMID: 22307320 BACKGROUND

• Johnson EM, Saltzman DA, Suh G, Dahms RA, Leonard AS. Complications and risks of central venous catheter placement in children. Surgery. 1998 Nov;124(5):911-6.

  PMID: 9823406 BACKGROUND

• Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.

  PMID: 17875082 BACKGROUND

• Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.

  PMID: 12797890 BACKGROUND

• Hilty WM, Hudson PA, Levitt MA, Hall JB. Real-time ultrasound-guided femoral vein catheterization during cardiopulmonary resuscitation. Ann Emerg Med. 1997 Mar;29(3):331-6; discussion 337. doi: 10.1016/s0196-0644(97)70344-5.

  PMID: 9055771 BACKGROUND

• Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Ultrasound-guided internal jugular venous cannulation in infants: a prospective comparison with the traditional palpation method. Anesthesiology. 1999 Jul;91(1):71-7. doi: 10.1097/00000542-199907000-00013.

  PMID: 10422930 BACKGROUND

• Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.

  PMID: 11012954 BACKGROUND

• Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.

  PMID: 15121722 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

• Turker G, Kaya FN, Gurbet A, Aksu H, Erdogan C, Atlas A. Internal jugular vein cannulation: an ultrasound-guided technique versus a landmark-guided technique. Clinics (Sao Paulo). 2009;64(10):989-92. doi: 10.1590/S1807-59322009001000009.

  PMID: 19841706 BACKGROUND

• Mitre CI, Golea A, Acalovschi I, Mocan T, Caea AM, Ruta C, Mariana M. Ultrasound-guided external jugular vein cannulation for central venous access by inexperienced trainees. Eur J Anaesthesiol. 2010 Mar;27(3):300-3. doi: 10.1097/EJA.0b013e328333c2d6.

  PMID: 19935072 BACKGROUND

• Prabhu MV, Juneja D, Gopal PB, Sathyanarayanan M, Subhramanyam S, Gandhe S, Nayak KS. Ultrasound-guided femoral dialysis access placement: a single-center randomized trial. Clin J Am Soc Nephrol. 2010 Feb;5(2):235-9. doi: 10.2215/CJN.04920709. Epub 2009 Dec 3.

  PMID: 19965532 BACKGROUND

• Fragou M, Gravvanis A, Dimitriou V, Papalois A, Kouraklis G, Karabinis A, Saranteas T, Poularas J, Papanikolaou J, Davlouros P, Labropoulos N, Karakitsos D. Real-time ultrasound-guided subclavian vein cannulation versus the landmark method in critical care patients: a prospective randomized study. Crit Care Med. 2011 Jul;39(7):1607-12. doi: 10.1097/CCM.0b013e318218a1ae.

  PMID: 21494105 BACKGROUND

• Yonei A, Nonoue T, Sari A. Real-time ultrasonic guidance for percutaneous puncture of the internal jugular vein. Anesthesiology. 1986 Jun;64(6):830-1. doi: 10.1097/00000542-198606000-00033. No abstract available.

  PMID: 3717653 BACKGROUND

• Weiner MM, Geldard P, Mittnacht AJ. Ultrasound-guided vascular access: a comprehensive review. J Cardiothorac Vasc Anesth. 2013 Apr;27(2):345-60. doi: 10.1053/j.jvca.2012.07.007. Epub 2012 Sep 18. No abstract available.

  PMID: 22995457 BACKGROUND

• Iwashima S, Ishikawa T, Ohzeki T. Ultrasound-guided versus landmark-guided femoral vein access in pediatric cardiac catheterization. Pediatr Cardiol. 2008 Mar;29(2):339-42. doi: 10.1007/s00246-007-9066-2. Epub 2007 Sep 13.

  PMID: 17851631 BACKGROUND

• Aouad MT, Kanazi GE, Abdallah FW, Moukaddem FH, Turbay MJ, Obeid MY, Siddik-Sayyid SM. Femoral vein cannulation performed by residents: a comparison between ultrasound-guided and landmark technique in infants and children undergoing cardiac surgery. Anesth Analg. 2010 Sep;111(3):724-8. doi: 10.1213/ANE.0b013e3181e9c475. Epub 2010 Jul 2.

  PMID: 20601450 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

• Mansfield PF, Hohn DC, Fornage BD, Gregurich MA, Ota DM. Complications and failures of subclavian-vein catheterization. N Engl J Med. 1994 Dec 29;331(26):1735-8. doi: 10.1056/NEJM199412293312602.

  PMID: 7984193 BACKGROUND

• Klerk CP, Smorenburg SM, Buller HR. Thrombosis prophylaxis in patient populations with a central venous catheter: a systematic review. Arch Intern Med. 2003 Sep 8;163(16):1913-21. doi: 10.1001/archinte.163.16.1913.

  PMID: 12963564 BACKGROUND

• Lamperti M, Bodenham AR, Pittiruti M, Blaivas M, Augoustides JG, Elbarbary M, Pirotte T, Karakitsos D, Ledonne J, Doniger S, Scoppettuolo G, Feller-Kopman D, Schummer W, Biffi R, Desruennes E, Melniker LA, Verghese ST. International evidence-based recommendations on ultrasound-guided vascular access. Intensive Care Med. 2012 Jul;38(7):1105-17. doi: 10.1007/s00134-012-2597-x. Epub 2012 May 22.

  PMID: 22614241 BACKGROUND

MeSH Terms

Interventions

Central Venous Catheters

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Results Point of Contact

• Title: Dr. Pietro Pietroboni Fuster
• Organization: Universidad de Chile

pietroboni@gmail.com

+56982261539

Study Officials

• Pietro F Pietroboni, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Cristian Carvajal, MD, Mg

  Hospital Roberto del Río

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medico Pediatra

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 17, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 30, 2017
• Results First Posted: December 15, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)